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
Amarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world.
Availability of Other Information About Amarin
Investors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Amarin Contact Information
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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.
2National Center for Health Statistics. Multiple Cause of Death 2018–2021 on CDC WONDER Database. Accessed February 2, 2023.
3American Heart Association, Cardiovascular Disease: A Costly Burden For America Projections Through 2035 (2017).
4 FDA, NDA 22224/S-011, Trilipix (fenofibric acid) Approval Letter (Apr. 27, 2015) (removing the indication and related labeling statements).
5 [Database footnote.] This estimate is calculated using product wholesale acquisition cost (WAC) and does not account for any manufacturer discounts and rebates related to such products.
6 IQVIA data.
7 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines, Circulation. 2023;148:e00–e00 (July 2023), DOI: 10.1161/CIR.0000000000001168, at e29.
8 The FIELD Study Investigators, Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (“FIELD Study”): randomised controlled trial, The Lancet 366 (Nov. 26, 2005).
9 The ACCORD Study Group, Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus, NEJM 362:1563-1574 (Apr. 29, 2010) (“ACCORD Lipid Study”)
10 A.D. Pradhan et al., Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk, NEJM 387:1923 (2022) (“PROMINENT Study”).
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