Latest news with #FDA
Medscape
2 hours ago
- Health
- Medscape
BMJ Investigation Increases Concerns About Ticagrelor Trials
An investigation by The BMJ is raising fresh concerns about the clinical studies that supported the approval of the antiplatelet drug ticagrelor (Brilinta, AstraZeneca), almost 15 years after the medication was first approved and as generic versions are set to hit the market. Peter Doshi, PhD, a senior editor at The BMJ , previously reported inconsistencies and omissions in data reporting from the 2009 PLATO study, published in The New England Journal of Medicine , which showed ticagrelor was superior to clopidogrel in treating acute coronary syndrome. Now a follow-up investigation of two supporting studies published in Circulation , ONSET/OFFSET and RESPOND, has revealed primary endpoints were reported inaccurately, data were missing from the submission to the US Food and Drug Administration (FDA), and study centers may not have received adequate training. Doshi said the results of his investigations call into question the drug's approval and suggested that it should be revisited. 'The FDA's approval in 2011 went against the evidence according to its reviewers, and now, my investigations into PLATO, ONSET/OFFSET, and RESPOND, suggest that even the data presented to the FDA and reported in The New England Journal of Medicine and Circulation , is not trustworthy,' he told Medscape Medical News. The investigation identified several problems with data integrity in the two trials. The original primary endpoint results for RESPOND, which aimed to test whether ticagrelor could convert nonresponders to clopidogrel into responders, were statistically nonsignificant ( P = .157) but were subsequently reported in Circulation as significant ( P = .005) because of an undeclared change in its primary endpoint definition. For ONSET/OFFSET, which reported ticagrelor provided faster and greater inhibition of platelets than clopidogrel, the investigators now claim several patients were excluded from the analysis. However, those who remained were identified as the 'intention-to-treat' population, implying all patients were included. Implausible data points were also included in the analysis of the primary endpoint but were first transformed through an unpublished data analysis, Doshi claimed. Doshi also gained access to readouts from some of the platelet function test machines used in the trial. He found more than 60 of 282 readings were not present in the datasets submitted to the FDA, and the levels of platelet activity in those readings were significantly higher than those reported in Circulation . Victor Serebruany, MD, from Johns Hopkins University in Baltimore, and one of the more high-profile critics of ticagrelor, told The BMJ the missing readings show 'there are episodes of skyrocketing rebound and profound platelet inhibition after ticagrelor, making patients prone to thrombosis or bleeding. If doctors had known what happened in these trials, they would never have started using ticagrelor.' The investigation also revealed oddities around the authorship of the publications. One active trial investigator was never identified as a study author, while one author told The BMJ he was not involved in the trial. The BMJ states that AstraZeneca, the journal Circulation , and many of the original investigators either declined to comment on the new claims or were unreachable. Ticagrelor has been under fire since the beginning. The drug failed in its first bid for FDA approval and was the subject of an investigation by the US Department of Justice in 2013 at the urging of Serebruany. That investigation was closed in 2014 with no further action. A review of several major trials of ticagrelor by Eric Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor, Michigan, and a co-author of the US guidelines that recommend ticagrelor, concluded 'the clinical conventional wisdom and clinical trial guideline support for…ticagrelor compared with clopidogrel may be overemphasized.' Bates is now calling for a review of ticagrelor's recommendation in guidelines, according to the earlier The BMJ report.
Medscape
5 hours ago
- Health
- Medscape
ACC Revises Obesity Control Strategies in Heart Failure
A new Scientific Statement from the American College of Cardiology (ACC) has named two anti-obesity drugs as options for symptom control in patients with heart failure. The benefit for these incretin mimics, semaglutide and tirzepatide, is attributed to symptom control, according to the statement. The document, published on June 13 in the Journal of the American College of Cardiology , states that each medication has the potential to reduce cardiovascular (CV) events related to heart failure, but neither has yet done so on the basis of level 1 evidence. The new recommendation appl ies only to heart failure with preserved ejection fraction (HFpEF). The safety and efficacy of these drugs has yet to be established for heart failure with reduced ejection fraction (HFrEF), according to the ACC statement. The new anti-obesity drugs were approved initially for type 2 diabetes. On the basis of substantial weight loss and their relative safety, the FDA subsequently granted indications for obesity alone in patients with at least one additional obesity-related comorbidity, such as hypertension, dyslipidemia, or obstructive sleep apnea. Current Indications for Incretin Mimetics Semaglutide has an indication for patients with CV disease, but not heart failure specifically, and obesity on the basis of the 2023 SELECT trial. Tirzepatide has an indication for patients with sleep apnea and obesity in the absence of diabetes on the basis of the 2024 SURMOUNT-OSA trial. In the 2023 STEP-HFpEF trial with semaglutide and the 2025 SUMMIT trial with tirzepatide, each agent was associated with a reduction in symptoms of heart failure in patients with HFpEF. However, the study designs and outcomes differed. For one, the HFpEF entry criterion was a left ventricular ejection fraction ≥ 45% in STEP-HFpEF but ≥ 50% in the SUMMIT trial. In dual primary endpoints, both included changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ), but the first of the two trials evaluated weight change, while the second evaluated a composite endpoint of CV death and heart failure-related events. By listing semaglutide and tirzepatide as options within a comprehensive review of the treatment of obesity in heart failure, the new document steps in front of current regulatory guidance. In a table that juxtaposed FDA-approved indications for these drugs to evidence-based benefits as defined by the statement, only the latter identifies a role in heart failure. 'The intent of the Writing Committee in including this table was to highlight that there are no FDA-approved heart failure indications for the use of incretin-based anti-obesity medications to date,' said Michelle M. Kittleson, MD, PhD, director of Heart Failure Research at Cedars-Sinai Medical Center in Los Angeles, who chaired the committee. 'While clinicians might identify individuals with heart failure who meet the standard FDA-approved indications, it is important to also identify which of those patients also meet inclusion criteria for th e heart failure trials were benefit was shown,' Kittleson said. Semaglutide acts on the GLP-1 receptor alone. Tirzepatide is an agonist of both the GLP-1 receptor and glucose-dependent insulinotropic polypeptide. Both drugs are associated with strong signals of CV benefit overall and in heart failure specifically, even if the evidence in HFpEF is 'stronger,' according to the statement. Incretin drugs mimic hormones that downregulate appetite. They are considered third-generation anti-obesity agents on the basis of their targeted mechanism and a low relative risk for adverse events. More than a dozen such agents are now in various stages of development, according to the ACC statement. Semaglutide and Tirzepatide Trials Differ In the STEP-HFpEF trial, which like SUMMIT trial, was placebo controlled, the 7.8-point gain ( P <.0001) in the KCCQ on active therapy vs placebo was statistically significant, as was the percent body weight loss (-13.3% vs -2.6%; P < .001). The SUMMIT trial found a 6.9-point gain in the KCCQ score ( P < .001) relative to placebo, while the rate the composite event endpoint of CV death from events associated with heart failure was lower (9.9% vs 15.3%; P = .026), but CV deaths occurred in only 13 patients. Heart failure events were observed in 81 patients over 2 years of follow-up. In both studies, significant gains in the secondary endpoints of physical and exercise function were associated with the assigned weight-loss drug. On the evidence so far, the authors of the ACC statement concluded that despite the marginal benefit observed in the SUMMIT trial, no firm conclusions can be made about the ability of incretin therapies to protect patients with HFpEF against hard endpoints, Kittleson said. Until more data are available, she cautioned against the risk for 'indication creep,' the willingness to offer these drugs for potential benefits that have yet to be confirmed. Still, she added, 'the goal of the writing group was to strike a tone of cautious optimism guided by the available data.' Part of this optimism has been fueled by the 2023 SELECT trial, which enrolled more than 17,000 patients with overweight with CV disease but no diabetes. Relative to placebo, semaglutide was associated with a 20% reduction ( P < .001) in the composite primary endpoint of CV death, nonfatal myocardial infarction, and nonfatal stroke. Only 24% of patients in this study had heart failure, but the risk reduction in this group was consistent with that of the study population as a whole. Obesity is listed in most guidelines, including a 2024 ACC Expert Consensus Decision Pathway for Treatment of HFrEF, as a common comorbidity of heart failure and potentially treatable risk factor for symptoms and progression of the condition. However, the new statement differs from prior guidelines. Typically, lifestyle modifications are identified as a first step toward weight loss. 'Patients should not be required to try and fail lifestyle changes prior to initiating pharmacotherapy,' according to Olivia Gilbert, MD, a cardiologist specializing in advanced heart failure and transplantation at Atrium Wake Forest Baptist Medical Center, in Wake Forest, North Carolina. Although Gilbert was not part of the writing committee for the new document, she has been involved in developing clinical guidance statements for the ACC. The incretin therapies are more effective than lifestyle medications and safer than procedure-based weight-loss interventions, Gilbert said, providing a basis for suggesting they can be considered first line therapy for patients with symptomatic HFpEF. 'Lifestyle interventions should always be offered in conjunction with obesity medications,' she said.
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Business Standard
5 hours ago
- Health
- Business Standard
USFDA approves first HIV prevention shot needing only two doses a year
Even after decades of medical progress, HIV continues to infect thousands globally each day, according to estimates by the World Health Organization. In a major breakthrough, the US Food and Drug Administration (FDA) on Thursday approved lenacapavir, a long-acting injectable drug that offers near-complete protection against HIV with just two doses a year. Lenacapavir, developed by Gilead Sciences and marketed under the brand name Yeztugo, is the world's first twice-yearly HIV prevention shot. It could transform pre-exposure prophylaxis (PrEP) options, particularly for those who struggle with daily medication adherence due to stigma, access issues, or lifestyle factors. How does lenacapavir work? Lenacapavir is a capsid inhibitor, a class of drugs that blocks the protein shell (capsid) the HIV virus needs to replicate. Unlike oral PrEP pills that must be taken daily, lenacapavir is administered as an injection once every six months, providing a discreet and highly effective method of prevention. How effective is lenacapavir against HIV? In two large-scale clinical trials conducted by Gilead: The first trial involved over 2,000 women in sub-Saharan Africa and showed a 100 per cent reduction in HIV infections, outperforming the daily oral PrEP pill Truvada. The second trial, involving over 2,000 men and gender-diverse individuals, reported only two infections, yielding a 99.9 per cent prevention rate. 'This medicine only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention,' said Daniel O'Day, Chairman and CEO of Gilead Sciences. 'With the FDA approval of Yeztugo, we are one step closer to ending HIV.' Is lenacapavir safe? Clinical trials report that lenacapavir is well tolerated, with mild injection site reactions being the most common side effect. No serious safety concerns have emerged, making it a viable long-term option for prevention. Who stands to benefit the most? The twice-yearly dosing offers particular promise for: Young women LGBTQ+ individuals People in remote or underserved regions Public health experts say it will improve adherence and reduce infection rates in communities often left behind by daily-pill-based prevention strategies. When will lenacapavir be available outside the US? While the FDA has cleared the drug, approvals in other countries are still pending. Applications are under review in Europe, Australia, Canada, South Africa, Brazil, and Latin America. The World Health Organization is expected to release global guidance on July 14 during the International AIDS Conference in Kigali. How much will Yeztugo cost? Gilead has yet to announce the price of Yeztugo. However, analysts estimate that the US launch could cost up to $25,000 per year. Currently, lenacapavir is priced at $39,000 annually for HIV treatment use, though prices are expected to fall for prevention. Advocacy groups such as UNAIDS and Unitaid are calling for significant price reductions in low- and middle-income countries. Generic manufacturing is being explored, with estimates suggesting a potential price of $25–$46 per year if Gilead grants licences. What's the HIV situation in India? According to the National AIDS Control Organisation (NACO), an estimated 2.4 million people were living with HIV in India in 2021. That year, 41,970 AIDS-related deaths were recorded, underscoring the ongoing public health challenge.
Yahoo
6 hours ago
- Health
- Yahoo
Press Release: Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid
Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid Approval based on pivotal results showing improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo in adults with BP BP is a chronic, debilitating, and relapsing rare skin disease affecting approximately 27,000 adults in the US whose disease is uncontrolled by systemic corticosteroids Dupixent is now approved in the US to treat eight distinct diseases with underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system that affect a broad range of patients, from infants to elderly people Paris and Tarrytown, NY, June 20, 2025. The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP). BP primarily affects elderly patients, and is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient's immune system. Executive Director, International Pemphigus and Pemphigoid Foundation 'People affected by bullous pemphigoid endure unrelenting itch and painful blisters that can damage the skin. Until now, these primarily elderly patients have had limited therapeutic options available, with potential side effects that have often added to their burden. The approval of Dupixent for bullous pemphigoid brings a novel treatment approach to patients and their caregivers, and we are grateful for the tireless efforts of the scientific community who helped us reach this critical milestone.' Global Therapeutic Area Head, Immunology and Oncology Development, Sanofi 'Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions. By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch. This approval in the US is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.' The FDA approval is based on data from the pivotal ADEPT phase 2/3 study that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. During the FDA review, the analyses were updated; the FDA-approved results at 36 weeks in the label for Dupixent compared to placebo are: 18.3% of patients experienced sustained disease remission compared to 6.1% (12.2% difference; 95% confidence interval: -0.8% to 26.1%), the primary endpoint 38.3% of patients achieved clinically meaningful itch reduction compared to 10.5% Median cumulative OCS dose was 2.8 grams compared to 4.1 grams In this elderly population, the most common adverse events (≥2%) more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections, and keratitis. Additionally, one case of acute generalized exanthematous pustulosis was reported in one patient treated with Dupixent and zero patients treated with placebo. Board co-Chair, President, and Chief Scientific Officer at Regeneron 'This approval extends the remarkable ability of Dupixent to transform treatment paradigms for people living with a variety of diseases with underlying type 2 inflammation, from common conditions like asthma and atopic dermatitis, to rarer ones such as eosinophilic esophagitis and prurigo nodularis, and now including bullous pemphigoid. Dupixent has shown the potential to improve the most challenging effects of bullous pemphigoid, while helping some patients achieve sustained disease remission and decreased oral corticosteroid use. Additionally, this approval further reinforces the demonstrated safety profile of Dupixent in a broad age range of patients, from infants to elderly people, and across dermatological, respiratory, and gastrointestinal diseases.' The FDA evaluated Dupixent under priority review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP, which applies to investigational medicines intended for the treatment of rare diseases that affect fewer than 200,000 people in the US. Additional regulatory applications are also under review around the world, including in the EU, Japan, and China. About the Dupixent BP pivotal studyADEPT was a randomized, phase 2/3, double-blind, placebo-controlled study evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP for a 52-week treatment period. After randomization, patients received Dupixent or placebo every two weeks after an initial loading dose, along with OCS treatment. During treatment, OCS taper was initiated after patients experienced two weeks of sustained control of disease activity. OCS tapering could start between four to six weeks after randomization and was continued if disease control was maintained, with the intent of completion by 16 weeks. After OCS tapering, patients were only treated with Dupixent or placebo for at least 20 weeks (rescue treatment could be used if required). The primary endpoint evaluated the proportion of patients achieving sustained disease remission at 36 weeks. Sustained disease remission was defined as complete clinical remission with completion of OCS taper by 16 weeks without relapse after completion of the OCS taper and no rescue therapy use during the 36-week treatment period. Relapse was defined as appearance of ≥3 new lesions a month or ≥1 large lesion or urticarial plaque (>10 cm in diameter) that did not heal within a week. Rescue therapy could include treatment with high-potency topical corticosteroids, OCS (including increase of OCS dose during the taper or re-initiation of OCS after completion of the OCS taper), or systemic non-steroidal immunosuppressive medications, or immunomodulating biologics. Select secondary endpoints evaluated at 36 weeks included: Proportion of patients with ≥4-point reduction in Peak Pruritus Numerical Rating Scale (scale 0-10) Total cumulative OCS dose About DupixentDupixent (dupilumab) is an injection administered under the skin (subcutaneous injection) at different injection sites. In adults with BP, Dupixent 300 mg is administered every other week after an initial loading dose, and in combination with a tapering course of oral corticosteroids. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home after training by a healthcare professional. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL4) and interleukin-13 (IL13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 studies, establishing that IL4 and IL13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Sanofi and Regeneron are committed to helping patients in the US who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, and BP in different age populations. More than one million patients are being treated with Dupixent globally. Dupilumab development programDupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical studies involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in phase 3 studies, including chronic pruritus of unknown origin and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About RegeneronRegeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media RelationsSandrine Guendoul | +33 6 25 09 14 25 | Evan Berland | +1 215 432 0234 | Le Bourhis | +33 6 75 06 43 81 | Rouault | +33 6 70 93 71 40 | Gilbert | +1 516 521 2929 | Ubaldi | +33 6 30 19 66 46 | Sanofi Investor RelationsThomas Kudsk Larsen |+44 7545 513 693 | Kaisserian | +33 6 47 04 12 11 | Lauscher | +1 908 612 7239 | Browne | +1 781 249 1766 | Pham | +33 7 85 93 30 17 | Elgoutni | +1 617 710 3587 | Châtelet | +33 6 80 80 89 90 | Li | +33 6 84 00 90 72 | Regeneron Media RelationsAnna Hodge | +1 914-255-6475| Regeneron Investor RelationsMark Hudson | +1 914-847-3482 | Sanofi forward-looking statementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks mentioned in this press release are the property of the Sanofi group except for VelociSuite and Regeneron Genetics Center. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Dupixent® (dupilumab) for the treatment of bullous pemphigoid as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, lichen simplex chronicus, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024, and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Press_ReleaseError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
9 hours ago
- Health
- Business Upturn
HealthRX Expands Telehealth Website Experience to Include GLP-1 Weight Loss Solutions, Prescription Access, and 24/7 Wellness Support
BROOKLYN, June 19, 2025 (GLOBE NEWSWIRE) — HealthRX, a digital health platform serving adults across the United States, has announced an expanded online experience designed to support weight management and long-term wellness through a suite of integrated offerings. These include Health RX Telehealth™, Health RX Prescription Access™, and Health RX Wellness Support™, all accessible through its newly enhanced website at The update provides streamlined access to GLP-1 medications such as Ozempic®, Zepbound®, and compounded alternatives—subject to eligibility criteria and clinical discretion. The HealthRX platform is built to accommodate adults who are seeking a secure, doctor-supervised weight management option that minimizes barriers to care and supports routine-friendly wellness. A Digital Health Platform Designed for Results HealthRX offers a simplified path for adults to explore medically appropriate weight loss options from the comfort of home. Through the HealthRX intake process, users can connect with U.S.-licensed physicians to determine clinical eligibility for GLP-1 medications. The program emphasizes convenience and flexibility, removing the need for in-person consultations or insurance requirements. The platform's design integrates: Health RX Telehealth™ – Secure access to virtual consultations with board-certified physicians. – Secure access to virtual consultations with board-certified physicians. Health RX Prescription Access™ – Direct, encrypted coordination with pharmacies for prescription fulfillment and renewals. – Direct, encrypted coordination with pharmacies for prescription fulfillment and renewals. Health RX Wellness Support™ – A collection of tools including coaching support, educational resources, medication reminders, and outcome tracking. Each service is built to align with common adult health goals—particularly those related to sustained weight management. Full details are available on the official HealthRX website at Highlight on GLP-1 Medication Access: Ozempic®, Zepbound®, and Tirzepatide Options GLP-1 medications have emerged as a physician-supervised option for individuals managing obesity or weight-related conditions. HealthRX facilitates access to FDA-approved GLP-1 treatments such as Ozempic®, Zepbound®, and Tirzepatide®, as well as compounded GLP-1 or GLP-1/GIP medications based on clinical suitability. These medications work by targeting appetite regulation and glucose control pathways and are prescribed in accordance with FDA labeling or compound-specific clinical judgment. The HealthRX platform outlines potential usage scenarios, average pricing tiers, and expected timelines for prescription delivery—all while emphasizing that outcomes vary by individual. For medication access information, visit HealthRX also confirms that compounded medications offered through the platform are prepared in U.S.-based facilities in accordance with USP <795> and <797> standards. The company notes that compounded drug products are not FDA-approved, and eligibility is determined during the virtual consultation process with a licensed provider. Three-Step Process Designed for Accessibility Visitors to the website are guided through a simple three-step intake process: Take the Assessment – Users begin by completing a short clinical questionnaire to determine preliminary eligibility. Meet a Board-Certified Physician – Within 24 hours, eligible users are connected to a licensed medical provider for an evaluation. Receive Medication – Upon approval, GLP-1 prescriptions are delivered securely to the patient's door with ongoing support available. This process is designed to make adult wellness and weight loss support accessible without long wait times, insurance hassles, or frequent office visits. A full description is provided at Pricing and Support Structure As listed on the platform: Ozempic® (Brand GLP-1) – $1,299/month (In Stock) – $1,299/month (In Stock) Tirzepatide® (GLP-1 + GIP) – $1,299/month (Limited Stock) – $1,299/month (Limited Stock) GLP-1 Injections (Compounded) – $189/month (Low Stock) – $189/month (Low Stock) GLP-1 Oral Tablets (Compounded) – $239/month (Low Stock) – $239/month (Low Stock) GLP-1 + GIP Injection (Compounded) – $349/month (In Stock) Pricing reflects bundled services that include medical evaluation, platform access, prescription coordination, and support. Details and plan tiers are explained at Transparent Clinical Oversight All HealthRX-affiliated physicians are U.S.-licensed and board-certified in relevant specialties such as internal medicine, emergency care, osteopathic medicine, and family medicine. Provider credentials and bios are available through the HealthRX platform. HealthRX confirms that all consultations, messaging, and record keeping are conducted through encrypted channels in compliance with HIPAA regulations. Privacy and user consent policies are explained at Health RX Wellness Support™ Adds a Preventive Layer Health RX Wellness Support™ complements prescription and telehealth services by offering educational and lifestyle tools, including: Digital health journals and medication tracking Reminder alerts for check-ins and prescription refills Curated content on nutrition, movement, and self-care Access to secure provider messaging These tools aim to reinforce adherence and increase long-term success for adults pursuing medically guided weight loss. More about the support program can be found at Verified Customer Experiences HealthRX highlights verified user reviews collected by third-party platforms: 'Signing up took less than five minutes, and the process was clear.' 'The support staff answered every question. I already feel healthier.' 'After starting the treatment, I received my delivery within 48 hours.' Individual experiences are unique, and HealthRX maintains a strict no-guarantee policy regarding outcomes. Additional testimonials and review information are linked from Platform Policies and Consumer Disclosures HealthRX outlines its key platform policies, including: No charge if a user does not qualify Cancellation is available anytime without penalties Refunds are processed within 24–48 hours if eligibility is not met Insurance is not required but may be used independently for reimbursement These policies are detailed in the platform's Terms of Service and FAQ sections at About HealthRX HealthRX is a U.S.-based virtual healthcare platform offering GLP-1-based weight management, online prescription access, and ongoing support through secure telehealth services. The platform includes Health RX Telehealth™, Health RX Prescription Access™, and Health RX Wellness Support™, designed to provide adults with personalized, remote wellness strategies. HealthRX is not a healthcare provider itself, but coordinates licensed services through verified clinical partners. More about the HealthRX platform can be found at Product and Contact Information Products and Services: Health RX Telehealth™ Health RX Prescription Access™ Health RX Wellness Support™ GLP-1 Medications: Ozempic®, Zepbound®, Tirzepatide®, Compounded Options Website: Contact Email: [email protected] Phone: +1 (208) 494-2534 Disclaimer This release is for informational purposes only and does not constitute medical advice, diagnosis, or treatment. Individual results may vary. Consumers should consult a licensed medical provider for personalized recommendations. HealthRX does not guarantee eligibility, outcomes, or medication access. GLP-1 medications may cause serious side effects, including possible thyroid tumors. Do not use if you or a family member have a history of medullary thyroid carcinoma (MTC) or MEN 2. Compounded drugs are not FDA-approved, and their safety and effectiveness have not been evaluated by the FDA. HealthRX does not manufacture, prescribe, or dispense medication directly. All services are provided through licensed third parties. Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
