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Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event | ||
By: GlobeNewswire - 24 Apr 2024 | Back to overview list |
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Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect Patients DUBLIN, Ireland and BRIDGEWATER, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced its support for a petition filed with the U.S. Food and Drug Administration (FDA) requesting that the Commissioner focus on and take further action to address significant off-label prescribing of fenofibrates, due to the fact that multiple clinical trials have proven fenofibrates have no clinical benefit when used in combination with statins to reduce cardiovascular disease (CVD) risk. The filing comes as heart disease continues to be the leading cause of death in the United States, accounting for one in five deaths in 2021.1,2 Approximately 805,000 people in the United States have a heart attack each year, which amounts to one person every 40 seconds.1 The annual treatment cost for CVD is $555 billion, which is expected to double within 20 years.3 Despite the FDA mandating label changes in 2015 for fenofibrates,4 more than 11 million prescriptions were written and more than one million patients were treated with a fenofibrate in combination with a statin in 2023.5,6 Those patients are also being unnecessarily exposed to the serious side effects of fenofibrates and payors are subjected to unnecessary spending from off-label fenofibrate prescriptions. “Despite the many safe, effective, and FDA-approved treatments available on the market with clinically proven reductions of CVD risk, patients are still being treated with fenofibrates off-label. This results in patients taking a drug proven to have no clinical benefit to reduce CVD risk,” said Nabil Abadir, M.D., Chief Medical Officer at Amarin. “This is a significant issue that is risking patient health and should be addressed quickly by the FDA. We applaud HealthyWomen for taking action to help ensure patients get the best care possible for their CV health.” The petition, filed by HealthyWomen, the nation’s leading nonprofit dedicated to educating and empowering women to make informed decisions about their health, requests that the FDA require revised labelling for fenofibrate drugs to incorporate important results from recent clinical studies showing their ineffectiveness and to communicate this information with healthcare professionals and patients. The petition also urges the FDA Commissioner to further clarify the position the agency previously took by removing the statin co-administration from fenofibrate labeling. To view the petition, click here. The petition is supported by the recent 2023 American Heart Association/American College of Cardiology Joint Guidelines for the Management of Patients with Chronic Coronary Disease7 and CV outcomes trials such as the 2005 FIELD8 and 2010 ACCORD9 Lipid studies with fenofibrates that resulted in previous FDA action. More recently, the 2022 PROMINENT10 clinical trial yet again confirmed the lack of benefit of adding a fibrate to statin-treated patients in reducing CVD risk. “As heart disease is the leading cause of death in the United States, we cannot minimize the importance of taking effective and approved therapies to treat overall cardiovascular outcomes and not just lowering biomarker scores,” said Dr. Payal Kohli, Founder and Medical Director of Cherry Creek Health and Associate Professor of Medicine at the University of Colorado Anschutz Medical Campus. “Achieving better outcomes for people with a prior history or high-risk for cardiovascular disease starts with ensuring prescribers and patients know and implement the latest science in prescribing practices. By taking an unproven and ineffective treatment, patients are being put at unnecessary risk for a devastating cardiovascular event, like a heart attack or stroke, which also strains the healthcare system in the U.S.” This petition was received and processed under 21 CFR 10.30 by the FDA Office of Operations Dockets Management Staff on April 23, 2024 and it was assigned docket number FDA-2024-P-1988. About Amarin Availability of Other Information About Amarin Amarin Contact Information 1 Tsao CW, Aday AW, Almarzooq ZI, Beaton AZ, Bittencourt MS, Boehme AK, et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation. 2023;147:e93–e621. |
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