Latest news with #TheLancetInfectiousDiseases
Yahoo
10-06-2025
- Health
- Yahoo
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults
In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains. If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhea in decades. WALTHAM, Mass. & GENEVA, Switzerland, June 10, 2025--(BUSINESS WIRE)--Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc. (NASDAQ: INVA), in collaboration with the Global Antibiotic Research & Development Partnership (GARDP), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for zoliflodacin, the investigational first-in-class, single dose, spiropyrimidinetrione oral antibiotic for the treatment of uncomplicated gonorrhea in adults and pediatric patients 12 years and older. If approved, zoliflodacin would be the first new antibiotic for treating gonorrhea in decades. With more than 82 million new gonorrhea infections occurring globally each year, gonorrhea is the second most common bacterial sexually transmitted infection (STI), affecting both men and women, which, if left untreated, can result in serious and permanent health consequences. With the rise and spread of drug-resistant infections and the World Health Organization (WHO) identifying antimicrobial resistance (AMR) as one of the ten most critical global threats to public health, the bacterium Neisseria gonorrhoeae has progressively developed resistance to many classes of antibiotics used to treat these infections, including ceftriaxone, a widely used intramuscular injection that was first made available in 1984. "Today's acceptance of the zoliflodacin NDA marks significant progress toward delivering health care providers with a potential new oral treatment option for uncomplicated gonorrhea, including infections caused by drug-resistant strains," said David Altarac, M.D., Chief Medical Officer, Innoviva Specialty Therapeutics. "We look forward to working closely with the FDA during its review and, if approved, we are committed to expediting the availability of zoliflodacin to patients in the U.S." Recent reports (The Lancet Infectious Diseases) of emergent ceftriaxone-resistant infections have heightened the urgency for new antibiotics. Effective treatment options are essential to reducing the burden of disease for individuals and preventing the spread of highly drug-resistant gonorrhea globally. If left untreated, gonorrhea can also cause infertility in women, life-threatening ectopic pregnancies, and pelvic inflammatory disease.2 The FDA's acceptance of the zoliflodacin NDA is based on the totality of data collected from several clinical trials as part of an innovative public-private partnership with GARDP. These trials include a pivotal Phase 3 clinical trial which demonstrated non-inferiority in achieving microbiological cure at the urogenital site of infection of a single oral dose of zoliflodacin compared to a treatment regimen of a single intramuscular injection of ceftriaxone followed by 1 week of oral azithromycin. The Phase 3 study found that zoliflodacin was generally well-tolerated, with no serious adverse events or deaths reported during the trial. "This important milestone demonstrates the crucial role that public-private partnerships can play in tackling the escalating global antimicrobial resistance crisis," said Dr. Manica Balasegaram, Executive Director, Global Antibiotic Research Development Partnership (GARDP). "If zoliflodacin is approved, this collaboration paves the way for millions of people across the world to get access to a potentially powerful new drug to treat multidrug-resistant gonorrhea." Zoliflodacin has a unique mechanism of action, inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. In vitro studies have demonstrated its activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics. This investigational antibacterial is administered in a single, oral dose, simplifying treatment by providing a convenient option for patients unable to receive an intramuscular injection. The U.S. FDA has granted zoliflodacin a Qualified Infectious Disease Product (QIDP) designation. This designation allows it to benefit from FDA Priority Review, and Extended Market Exclusivity. Innoviva Specialty Therapeutics, Inc., anticipates that the NDA review will proceed according to the standard process for drugs with this designation. Entasis Therapeutics, Inc., the legal NDA holder and affiliate of Innoviva Specialty Therapeutics, Inc., retains the commercial rights for zoliflodacin in the major markets in North America, Europe, and Asia-Pacific. GARDP retains the right to register and commercialize the product in more than three-quarters of the world's countries, including all low-income countries, most middle-income countries, and several high-income countries. GARDP is committed to working with its partners and local health authorities in markets where zoliflodacin receives regulatory approval to help remove access barriers to ensure treatment is available to address unmet medical needs while ensuring appropriate and sustainable use. About GARDP The Global Antibiotic Research & Development Partnership (GARDP) is a not-for-profit global health organization driven to protect people from the rise and spread of drug-resistant infections, one of the biggest threats to us all. By forging the public and private partnerships that matter, we develop and make accessible antibiotic treatments for people who need them. Vital support for our work comes from the governments of Canada, Germany, Japan, Monaco, the Netherlands, Switzerland, the United Kingdom, the Canton of Geneva, the European Union, as well as the Gates Foundation, Global Health EDCTP3, GSK, the RIGHT Foundation, the South African Medical Research Council (SAMRC) and Wellcome. About Innoviva Innoviva is a diversified holding company with a core royalties portfolio, a leading critical care and infectious disease platform known as Innoviva Specialty Therapeutics ("IST"), and a portfolio of strategic investments in healthcare assets. Innoviva's royalty portfolio includes respiratory assets partnered with Glaxo Group Limited ("GSK"). Innoviva is entitled to receive royalties from GSK on sales of RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. Innoviva's other innovative healthcare assets include infectious disease and critical care assets stemming from acquisitions of Entasis Therapeutics, including XACDURO® (sulbactam for injection; durlobactam for injection), co-packaged for intravenous use approved for the treatment of adults with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex and the investigational zoliflodacin currently being developed for the treatment of uncomplicated gonorrhea, and La Jolla Pharmaceutical Company, including GIAPREZA® (angiotensin II), approved to increase blood pressure in adults with septic or other distributive shock and XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections in adults. On December 14, 2024, Innoviva entered into an exclusive distribution and license agreement with Basilea Pharmaceutica Ltd, Allschwil for the commercialization of ZEVTERA® (ceftobiprole), an advanced-generation cephalosporin antibiotic, in the U.S. For more information about Innoviva, go to For information about Innoviva Specialty Therapeutics, go to View source version on Contacts Media Contacts:Innoviva Specialty TherapeuticsDavid +1.908.421.5971GARDPDuncan Graham-Rowedgrahamrowe@ +44 7966 413623 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
India Today
02-06-2025
- Health
- India Today
Superbugs are spreading as India faces gaps in drug supply, access to treatment
While antibiotics are being overused in some places, leading to the rise of deadly superbugs, in other parts of the world, people are dying because they can't access these life-saving drugs at all.A study, published in The Lancet Infectious Diseases, was led by the Global Antibiotic Research and Development Partnership (GARDP), a non-profit that works to improve access to antibiotics, looked at nearly 1.5 million cases of infections caused by carbapenem-resistant Gram-negative (CRGN) bacteria across eight low- and middle-income countries, including India, Brazil, and South bacteria are dangerous because they are resistant to "last-line" antibiotics. These are medicines that are used when all others fail. Yet, the study found that only 6.9% of patients in these countries received the right CARRIES THE HEAVIEST BURDENIndia had the largest number of cases among all countries studied. It also procured 80% of the full antibiotic courses examined. But despite this, only 7.8% of people with CRGN infections received the proper points to a gap between drug supply and actual access to treatment.A full course of antibiotics means the complete number of doses a patient must take to fully fight off an infection. The study found that only 6.9% of patients in 8 countries, including India, received the right treatment. () advertisementMissing out on even a part of this treatment makes it less effective and more dangerous in the long drug-resistant bacteria are commonly found in water, food, the environment, and even in our own bodies. They can cause serious infections like urinary tract infections (UTIs), pneumonia, and food babies, elderly people, and hospital patients are especially at risk, particularly those in intensive care units (ICUs).CRGN infections are tough to treat because the bacteria no longer responds to some of the most powerful antibiotics we have. This is where the crisis deepens: in places where these infections are rising, the drugs needed to treat them are either missing or too ACCESS CRISISFor years, the focus has been on the overuse of to Dr. Jennifer Cohn, GARDP's Global Access Director, the reality is that many people in low- and middle-income countries with deadly drug-resistant infections are "dying because they can't get the antibiotics they need," she was quoted by study looked at eight different intravenous antibiotics that are active against these resistant bacteria. Bacterial infections are tough to treat because the bacteriano longer responds to some of the most powerful antibiotics we have. () Tigecycline, one of the drugs in the study, was the most widely used. But even then, only about 1 lakh full courses were available across all eight countries, far fewer than the 1.5 million people who needed ARE PATIENTS MISSING OUT?As per the study, there are many reasons why patients don't receive the right could be because they aren't reaching the right hospital or clinic, not getting an accurate diagnosis, not able to access the correct antibiotics or there's a high cost of newer of these antibiotics are simply too expensive for the average patient in countries like India. Without better policies, price regulation, and access programs, millions will continue to suffer or die POLICIESThe experts said that two things are needed urgently: stronger rules to prevent misuse of antibiotics and better systems to make them affordable and available to those who truly need access alone isn't enough. The world is also facing a shrinking pipeline of new fewer companies investing in antibiotic research, the options for treating future infections are has one of the highest burdens of antimicrobial resistance (AMR) in the world. But researchers say the country also holds great potential to lead the global fight against drug-resistant infections. India has one of the highest burdens of antimicrobial resistance (AMR) in the world. () India's strong pharmaceutical sector is already leading efforts in antibiotic innovation. From developing new drugs to improving diagnostics, the country has a head suggest that India can further improve by gathering local data. This would help identify what's needed, where the gaps are, and how to fix them. Some states are already trying new instance, Kerala is using a "hub-and-spoke" system where smaller clinics get support from larger hospitals in treating complex solution is pooled procurement, where hospitals or states buy drugs together in bulk, reducing costs. This has worked for cancer medicines and could be tried for antibiotics the end, the battle against superbugs is not just about using antibiotics wisely, it's also about making sure they're within everyone's Reel
Saudi Gazette
02-06-2025
- Health
- Saudi Gazette
Deadly superbugs thrive as access to antibiotics falters in India
DELHI — It's a grim paradox, doctors say. On the one hand, antibiotics are being overused until they no longer work, driving resistance and fuelling the rise of deadly superbugs. On the other hand, people are dying because they can't access these life-saving drugs. A new study by the non-profit Global Antibiotic Research and Development Partnership (GARDP) looked at access to antibiotics for nearly 1.5 million cases of carbapenem-resistant Gram-negative (CRGN) infections across eight major low- and middle-income countries, including India, Brazil and South Africa. CRGN bacteria are superbugs resistant to last-line antibiotics — yet only 6.9% of patients received appropriate treatment in the countries studied. India bore the lion's share of CRGN infections and treatment efforts, procuring 80% of the full courses of studied antibiotics but managing to treat only 7.8% of its estimated cases, the study in The Lancet Infectious Diseases journal reports. (A full drug course of antibiotics refers to the complete set of doses that a patient needs to take over a specific period to fully treat an infection.) Common in water, food, the environment and the human gut, Gram-negative bacteria cause infections such as urinary tract infections (UTIs), pneumonia and food poisoning. They can pose a serious threat to newborns and the elderly alike. Especially vulnerable are hospital patients with weakened immunity, often spreading rapidly in ICUs and proving difficult - and sometimes impossible - to treat. Treating carbapenem-resistant Gram-negative bacterial infections is doubly difficult because those bacteria are resistant to some of the most powerful antibiotics."These infections are a daily reality across all age groups," says Dr Abdul Gaffar, infectious disease consultant at Apollo Hospital in India's Chennai city. "We often see patients for whom no antibiotic works — and they die."The irony is cruel. While the world tries to curb antibiotic overuse, a parallel tragedy plays out quietly in poorer nations: people dying from treatable infections because the right drugs are out of reach."For years, the dominant narrative has been that antibiotics are being overused, but the stark reality is that many people with highly drug-resistant infections in low- and middle-income countries are not getting access to the antibiotics they need," says Dr Jennifer Cohn, GARDP's Global Access Director and senior author of the study examined eight intravenous drugs active against carbapenem-resistant bacteria - ranging from older antibiotics including Colistin to newer ones such as Ceftazidime-avibactam. Of the few available drugs, Tigecycline was the most widely blame the treatment gap on weak health systems and limited access to effective example, only 103,647 full treatment courses were procured of Tigecycline across eight countries — far short of the 1.5 million patients who needed them, the study found. This highlighted a major shortfall in the global response to drug-resistant prevents patients with drug-resistant infections in India from getting the right antibiotics?Physicians point to multiple barriers - reaching the right health facility, getting accurate diagnostic tests, and accessing effective drugs. Cost remains a major hurdle, with many of these antibiotics priced far beyond the reach of poorer patients."Those who can afford these antibiotics often overuse them; those who can't, don't get them at all," says Dr Gaffar. "We need a system that ensures access for the poor and prevents misuse by the well-to-do."To improve access, these drugs must be made more affordable. To prevent misuse, stronger regulation is key."Ideally, every antibiotic prescription in hospitals should require a second sign-off - by an infection specialist or microbiologist," says Dr Gaffar. "Some hospitals do this, but most don't. With the right oversight, regulators can ensure this becomes standard practice."To fix the access problem and curb misuse, both smarter policies and stronger safeguards are essential, say researchers. But access alone won't solve the crisis - the pipeline of new antibiotics is drying up. The decline in antibiotic R&D - and the limited availability of existing drugs - is a global bears one of the world's heaviest burdens of antimicrobial resistance (AMR), but it may also hold the key to combating it - both at home and globally, researchers say."India is also one of the largest markets for new antibiotics and can successfully advocate for the development and access of new antibiotics," says Dr Cohn. With a strong pharmaceutical base, the country is emerging as a hub for AMR innovation, from promising new antibiotics to advanced Cohn says India can strengthen its antibiotic response by generating local data to better estimate needs and pinpoint gaps in the care would allow for more targeted interventions to improve access to the right models are already emerging - Kerala state, for instance, is using a "hub-and-spoke approach" to support lower-level facilities in managing serious infections. Coordinated or pooled procurement across hospitals or states could also reduce the cost of newer antibiotics, as seen with cancer drug programs, researchers access to the right antibiotics, modern medicine begins to unravel - doctors risk losing the ability to safely perform surgery, treat complications in cancer patients, or manage everyday infections."As an infectious disease doctor, I see appropriate use as one part - but only one part - of access," says Dr Gaffar. "When we get new antibiotics, it's important to save them on one hand - and save them for right patients."Clearly, the challenge is not just to use antibiotics wisely, but to ensure they reach those who need them most. — BBC
Yahoo
13-05-2025
- Health
- Yahoo
Study uncovers alarming prevalence of disease linked to stillbirths: 'Will become even more widespread in the future'
A new study has revealed that Oropouche virus may be more prevalent in Latin America than initially believed — and it may be negatively impacting a vulnerable population. Oropouche virus is a vector-borne disease, which means that a living organism is what passes it on to humans. In this case, mosquitoes and biting midges (a kind of fly) are the vectors that transmit Oropouche. According to The Telegraph, Oropouche virus was found outside of its endemic area of Brazil for the first time in October 2023. While the World Health Organization says it was also detected in Trinidad and Tobago in 1955, it has spread "rapidly" to other South American and Caribbean countries since the 2023 discovery, per the report. In fact, a study published in The Lancet Infectious Diseases suggests that Oropouche's stint in those regions may have started as early as 2001. Researchers analyzed 9,400 blood samples from 2001 to 2022 from patients in Bolivia, Colombia, Costa Rica, Ecuador, and Peru. They found that 6.3% of individuals had Oropouche antibodies, indicating they were previously infected with Oropouche virus. While there is still a lot that researchers don't know about Oropouche virus, The Telegraph says it has been linked to stillbirths and birth defects. Pregnant people and their children are the most vulnerable to this disease. The study also found that the El Niño phenomenon accelerates Oropouche transmission. El Niño creates warmer and wetter weather, and Earth's warming climate — driven by human activities, mostly the burning of dirty fuels — has amplified this phenomenon over time. This weather allows mosquitoes and biting midges to thrive and infect more people, which spells health and environmental problems. "I think it's possible that Oropouche virus will become even more widespread in the future as climate change progresses," Dr. Jan Drexler, the head of the Virus Epidemiology Laboratory at the Institute of Virology at Charité and lead author of the study, told The Telegraph. Stopping the transmission of Oropouche virus can help keep global communities safe. Taking action to protect the environment can be one of the best ways to do this. Do you worry about getting diseases from bug bites? Absolutely Only when I'm camping or hiking Not really Never Click your choice to see results and speak your mind. Individuals can help by reducing their heat-trapping pollution through adopting energy-efficient appliances, taking public transportation, and installing solar panels, among other things. There is no treatment for Oropouche virus, so the best way to protect yourself is to be preventative. There are many ways to protect yourself from Oropouche virus and other diseases, such as Zika and West Nile, that are transmitted by mosquitoes. The WHO recommends using mesh bed nets, chemical insecticides, protective clothing, and insect repellents. The authors of the study also recommend that health care workers in the Americas familiarize themselves with the signs and symptoms of Oropouche virus, per The Telegraph. These include fever, headaches, and muscle pain. The symptoms may overlap with those of other illnesses such as dengue fever, as the WHO explains, but knowing that Oropouche is an option may help with diagnoses and treatments. Join our free newsletter for weekly updates on the latest innovations improving our lives and shaping our future, and don't miss this cool list of easy ways to help yourself while helping the planet.
The Hindu
06-05-2025
- Health
- The Hindu
Only 8% of bacterial infections in India treated appropriately in 2019: Lancet study
Only about 8% of bacterial infections detected in 2019 in India were treated appropriately, according to an analysis of low- and middle-income countries. Rising threat of drug-resistant infections Findings published in The Lancet Infectious Diseases journal show that in 2019, there were nearly 15 lakh bacterial infections resistant to carbapenems -- a common antibiotic -- across eight countries that were under study. Carbapenems are used for treating severe infections -- such as those acquired from being inside a hospital, where bacteria resistant to antibiotics are abundant. Of the 15 lakh bacterial infections, only over a lakh treatment courses were procured -- the resulting treatment gap meant that only 6.9% of the patients were treated appropriately, researchers, including those from the Global Antibiotic Research and Development Partnership (GARDP), Switzerland, found. Treatment gaps in low- and middle-income countries "India procured most of the treatment courses (80.5 per cent; 83,468 courses), with 7.8% of infections treated appropriately," the authors wrote. The eight countries that were part of the study included Bangladesh, Pakistan and Mexico. The most-procured antibiotic was tigecycline -- usually prescribed in hospitals for serious infections. Most of the 15 lakh infections were found to have occurred in South Asia, with over 10 lakh infections estimated to have occurred in India. Burden of bacterial antimicrobial resistance and need for better action plans Antibiotic, or antimicrobial, resistance is emerging as a major public health, with a 2024 Lancet study projecting over 39 million around the world could die due to such infections in the coming 25 years -- most of these could occur in South Asia, it said. The study also estimated that over a million died every year during 1990-2021 from antibiotic resistance, in which disease-causing bacteria become immune to drugs developed to kill them, thereby rendering these drugs ineffective. For this study, data from a systematic analysis of the burden of bacterial antimicrobial resistance from 1990 to 2021 -- named 'GRAM' study -- was analysed, along with that from a health-care database managed by IQVIA, a US-based life sciences company. The authors said the findings highlight the most recently available picture of the state of care for antimicrobial-resistant infections in the selected low- and middle-income countries. The results also underscore the need for meaningful action by global and national policy makers, the team said.
