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Korea Herald
6 days ago
- Business
- Korea Herald
Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients
INCHEON, South Korea, June 16, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA ® (ustekinumab-stba), a biosimilar to STELARA ® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). [1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. "Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." "We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages." The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. [2], [3] The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Notes to Editors: About STEQEYMA ® (ustekinumab-stba) STEQEYMA ®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA ® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS IMPORTANT SAFETY INFORMATION For more information, see Full Prescribing Information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA ® (infliximab-dyyb), TRUXIMA ® (rituximab-abbs), HERZUMA ® (trastuzumab-pkrb), VEGZELMA ® (bevacizumab-adcd), YUFLYMA ® (adalimumab-aaty), AVTOZMA ® (tocilizumab-anho), STEQEYMA ® (ustekinumab-stba), STOBOCLO ® (denosumab-bmwo), OSENVELT ® (denosumab-bmwo) and OMLYCLO ® (omalizumab-igec), as well as the novel biologic ZYMFENTRA ® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on our social media: LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws.
Medscape
04-06-2025
- General
- Medscape
Methotrexate Adds No Benefit to Adalimumab in Psoriasis
In adults with psoriasis, adding methotrexate to adalimumab did not improve effectiveness or drug survival compared with adalimumab alone, according to a UK cohort study of patients with plaque psoriasis. METHODOLOGY: Researchers emulated a target trial using data on 1784 patients with moderate to severe plaque psoriasis treated with systemic medications from the British Association of Dermatologists Biologic and Immunomodulators Register between 2007 and 2021. Participants received either adalimumab monotherapy (n = 1553) or adalimumab plus methotrexate (n = 231). The primary outcome was the difference in adalimumab drug survival at 1 year. Secondary outcomes were the proportion of patients achieving a 75% reduction in the Psoriasis Area and Severity Index (PASI 75), adverse events, and adalimumab drug and antidrug antibody levels. TAKEAWAY: Drug survival was not significantly different with combination therapy compared with adalimumab alone at 1 year (79.1% vs 78.1%) and 3 years (59.3% vs 57.2%). At 1 year, PASI 75 was achieved by 52% vs 49.4% of patients in the monotherapy group vs the combination therapy group. Rates were 32.4% vs 37.2%, respectively, at 3 years. Serious adverse event rates were similar between the two treatment groups: At 1 year, 7.8% vs 5.9% in the combination group vs the monotherapy group. The combination therapy group had a lower antidrug antibody level (mean difference, −123.7 AU/mL) and numerically higher estimated drug concentration level (1.3 mcg/mL) than the monotherapy group. IN PRACTICE: 'This target trial emulation cohort study did not find evidence that adding methotrexate to adalimumab was beneficial for treating plaque psoriasis,' the study authors wrote. 'Future studies evaluating the effect of concomitant methotrexate should either focus on high (> 10 mg/wk) dosing regimens with biologics other than adalimumab for treating plaque psoriasis or with adalimumab for other inflammatory skin diseases,' they added. SOURCE: The study was led by Zenas Yiu, PhD, Centre for Dermatology Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, University of Manchester, Manchester, England, and was published online on June 4 in JAMA Dermatology . LIMITATIONS: Most of the study participants deviated from treatment allocation and had missing outcome data, leading to inaccuracy of relative treatment effects measured by PASI and pharmacokinetic outcomes. Effect estimates in the intervention group lacked precision across all outcomes. Quality-of-life outcomes and baseline adjustment were omitted due to high levels of missing data. As an observational study, participants were unblinded to treatment allocation, introducing potential detection bias. DISCLOSURES: This study was supported by the National Institute for Health and Care Research Manchester Biomedical Research Centre. Several authors reported receiving grants or personal fees and having other ties with various sources.
Business Standard
04-06-2025
- Business
- Business Standard
SPARC tanks after psoriasis, eczema drug flunks Phase 2 trials
Sun Pharma Advanced Research Company (SPARC) dropped 18.63% to Rs 159.15 after the company announced disappointing results from a key clinical trial. In a regulatory filing, SPARC said that its partner, Sun Pharmaceutical Industries (SPIL), reported top-line results from Phase 2 studies of Vibozilimod (SCD-044), a drug candidate aimed at treating moderate-to-severe psoriasis and atopic dermatitis. Both trials failed to meet their primary endpoints: a 75% improvement in the Psoriasis Area and Severity Index (PASI75) and Eczema Area and Severity Index (EASI75), respectively, by Week 16. Following the setback, SPARC and SPIL stated they would assess the appropriate next steps for the development of Vibozilimod. SPARC is a clinical stage bio-pharmaceutical company focused on continuously improving standards of care for patients globally, through innovation in therapeutics and delivery. On a consolidated basis, SPARC reported net loss of Rs 59.77 crore in Q4 March 2025 as against net loss of Rs 105.79 crore in Q4 March 2024. Net sales rose 64.19% year-on-year to Rs 27.19 crore in Q4 March 2025.
Time of India
25-05-2025
- Health
- Time of India
CIMAP's cream for psoriasis set to take market by storm
Lucknow: CSIR Central Institute of Medicinal and Aromatic Plants (CIMAP) has developed a new herbal solution for psoriasis, a chronic autoimmune skin disease that causes thick, red, scaly patches (plaques) on the skin. The scientific institute introduced PsoriaCIM, a new lavender-based, expertly crafted cream formulation designed to treat the skin disease safely and effectively. While a patent is pending, CIMAP has successfully transferred its technology to a Lucknow-based private firm for commercial production. "The herbal formulation has been created solely for psoriasis, a very common disease which affects around 2–3% of the world's population, including a notable burden in India (0.44% to 2.8%). It is also associated with cardiovascular, metabolic, and psychiatric conditions," said chief investigator and senior principal scientist NP Yadav. "The available treatments for psoriasis contain corticosteroids, which have significant side effects. Our product is a unique combination of phytomolecules obtained from lavender oil, which is safe and as effective as steroid-based treatment available in the market," said chief investigator and senior principal scientist NP Yadav. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Giao dịch vàng với sàn môi giới tin cậy IC Markets Đăng ký Undo "It has shown remarkable performance in preclinical models, demonstrating significant efficacy in mitigating psoriatic inflammation, and was found to match the effects of 0.1% mometasone cream, a widely used steroid-based therapy," the scientist said. He further explained that this breakthrough research was launched after extensive in-vitro and in-vivo studies in rodent animals that revealed that the formulation demonstrates the synergistic effect of the combination, reducing the Psoriasis Area and Severity Index (PASI) scores significantly. To ensure its safety, skin irritation tests were conducted along with repeated dose dermal toxicity studies, confirming the formulation's skin-friendly and non-irritant nature. "PsoriaCIM is a scientifically validated formulation, developed through years of rigorous research that bridges the gap between traditional herbal wisdom and modern scientific innovation. "For over a decade, Yadav and his team dedicated themselves to developing a nature-inspired solution for psoriasis," said CSIR CIMAP director Prabodh Kumar Trivedi. CIMAP's head of business development, RK Srivastava, said that technology transfer of PsoriaCIM marks a significant step forward in harnessing the power of medicinal and aromatic plants.
Yahoo
21-05-2025
- Business
- Yahoo
Accropeutics Announces Positive Data from Phase 2 Trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, for the treatment of Moderate-to-Severe Plaque Psoriasis
Phase 2 primary endpoint of PASI-75 and key secondary endpoints met in all of the three dosing groups at Week 12 AC-201 was generally well tolerated at all dose levels with no SAEs or AEs leading to discontinuation Efficacy and safety findings from this Phase 2 trial support advancing AC-201 into Phase 3 development for plaque psoriasis. NEW YORK and SUZHOU, China, May 20, 2025 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited (Accropeutics), a clinical-stage biotech company focused on molecular mechanisms of regulated cell death and related pathogenesis in human diseases, today announced positive results from their Phase 2 clinical trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, in moderate-to-severe plaque psoriasis. Primary and key secondary endpoints including Psoriasis Area and Severity Index (PASI)-75, PASI-90(≥75% and 90% reduction in PASI) and static Physician's Global Assessment (sPGA)-0/1 (score of 0 'clear' or 1 'almost clear') were achieved following 12 weeks of treatment in all 3 dosing groups of AC-201. This multicenter, randomized, double-blind, placebo-controlled trial randomized (1:1:1:1) 145 Chinese patients with moderate to severe plaque psoriasis to receive AC-201 25mg BID, 50mg BID or 100mg QD versus placebo. The primary endpoint was PASI-75 at Week 12. At week 12, PASI-75 response rates were 8.1% for placebo (PBO), 31.4% for 25mg BID (P=0.012 vs. PBO), 74.3% for 50mg BID (P<0.001 vs. PBO), and 59.5% for 100mg QD (P<0.001 vs. PBO). The PASI-90 response rate was 2.7% for placebo, 20% for 25mg BID (P=0.02 vs. PBO), 48.6% for 50mg BID (P<0.001 vs. PBO), and 24.3% for 100mg QD (P=0.007 vs. PBO). The percent of patients achieved sPGA-0/1 were 5.4% for placebo, 71.4% for 50mg BID (P<0.001 vs. PBO), 59.5% for 100mg QD (P<0.001 vs. PBO), and 31.4% for 25mg BID (P=0.004 vs. PBO). Treatment with AC-201 was well tolerated. There was no serious adverse event (SAE) or AE leading to permanent discontinuation in the study. Majority of treatment emergent adverse events (TEAEs) were mild or moderate in severity. The most common TEAEs reported were upper respiratory tract infection and hypertriglyceridemia. Dr. Xiaohu Zhang, co-founder and CEO of Accropeutics, said, "We are excited to see the positive results from the phase II study of AC-201, and we will accelerate its clinical development to benefit patients with psoriasis and other autoimmune diseases." About AC-201 AC-201 is a novel, highly selective and potent oral small-molecule inhibitor of TYK2/JAK1 that binds to the pseudo kinase domain (JH2) of TYK2/JAK1, without having any effects on the JAK2/JAK2 signaling pathway. It is currently being developed to treat immune mediated inflammatory diseases such as psoriasis and systemic lupus erythematosus. AC-201 has successfully completed long-term nonclinical in vivo toxicology testing, including reproductive toxicity. Phase 1 studies of AC-201 in healthy volunteers conducted in Australia and China demonstrated an excellent safety and tolerability profile, supporting advancement into Phase 2. These studies showed dose proportional PK, no significant drug accumulation upon multiple dosing, and absence of clinically relevant food effect. Low to middle doses of AC-201 were effective in inhibiting disease causing pro-inflammatory cytokines, consistent with AC-201's mechanism of action. About Accropeutics Accropeutics is a clinical-stage biotech company with core focus on the molecular mechanisms of regulated cell death and related pathogenesis in human diseases. The company has developed a robust portfolio of innovative drug candidates spanning from lead optimization to clinical development. The RIPK1 inhibitor AC-003 had completed phase 1 clinical trials in China and the United States, obtained Orphan Drug Designation from the FDA, and is currently in a phase 1b trial for the treatment of aGVHD patients. The RIPK2 inhibitor AC-101 completed phase 1 testing in Australia and China with excellent safety and PK/PD data, and the 1b trial in UC patients is ongoing. AC-201, a selective TYK2/JAK1 inhibitor with therapeutic potential across a broad range of immune mediated inflammatory diseases, has completed a phase 2 clinical trial in Psoriasis with first-rate efficacy and safety findings. Accropeutics owns global rights of all the abovementioned assets with 24 patents issued in China, Japan, Korea, US and EU. Contact: info@ View original content: SOURCE Accropeutics Error 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
