Amarin Issues Statement Supporting FDA’s Action to Revise Labeling for Fenofibrate Drugs Reinforcing a Lack of Cardiovascular Benefit
Amarin Corporation plc - American Depositary Shares (AMRN)
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Source: GlobeNewswire
DUBLIN and BRIDGEWATER, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), a company committed to advancing the science of cardiovascular care worldwide, today issued the following statement in response to the recent action taken by the U.S. Food and Drug Administration (FDA) to update the labeling for fenofibrate drugs in association with cardiovascular care: We applaud the FDA’s decision to revise the labeling of fenofibrates (fibrates). The updated labeling now includes a clear statement on the lack of cardiovascular (CV) benefit, relevant safety data, and a refined indication as follows. “Fenofibrate did not reduce cardiovascular disease morbidity or mortality in two large, randomized controlled trials of patients with type 2 diabetes mellitus.” i“Risk for rhabdomyolysis is increased when fibrates are co-administered with a statin. Avoid concomitant use unless the benefit of further alterations in TG levels is likely to outweigh the increased risk
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- New REDUCE-IT® Aspirin Analysis Presented at AHA Scientific Sessions 2025 Reinforces VASCEPA®/VAZKEPA® (Icosapent Ethyl) Reduced Cardiovascular Events in High-Risk PatientsGlobeNewswire
- Amarin To Present New Analyses Affirming Robustness of Data from REDUCE-IT and Additional Mechanisms of Action of Eicosapentaenoic Acid (EPA) at American Heart Association (AHA) Scientific Sessions 2025GlobeNewswire
- Amarin (NASDAQ:AMRN) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=AMRN&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall Street Zen</a> froMarketBeat
- Amarin Reports Third Quarter 2025 Financial ResultsGlobeNewswire
- Amarin (NASDAQ:AMRN) was upgraded by analysts at Zacks Research from a "hold" rating to a "strong-buy" rating.MarketBeat
AMRN
Earnings
- 10/29/25 - Beat
AMRN
Sec Filings
- 10/31/25 - Form 3
- 10/29/25 - Form 10-Q
- 10/29/25 - Form 8-K
- AMRN's page on the SEC website