New REDUCE-IT Aspirin Analysis Presented at AHA Scientific Sessions 2025 Reinforces VASCEPA/VAZKEPA (Icosapent Ethyl) Reduced Cardiovascular Events in High-Risk Patients

DUBLIN and BRIDGEWATER, N.J., Nov. 09, 2025 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular care, today highlighted a new post hoc analysis of aspirin use in REDUCE-IT reinforcing that icosapent ethyl significantly reduced cardiovascular (CV) events in high-risk patients. These findings highlight the importance of guideline-directed therapies and further validate the role of icosapent ethyl in comprehensive CV risk management in appropriate patients as studied in REDUCE-IT. This analysis was presented soon after the U.S. Food and Drug Administration (FDA) updated labeling for fenofibrate (fibrates) products that now include language on the neutral PROMINENT trial, reinforcing the lack of CV benefit when fibrates were used alongside statins for cardiovascular risk reduction; a pivotal moment that underscores the need for more effective, evidence-based approaches to residual CV risk.

“Data presented at AHA are the direct result of our continued investments in supporting our VASCEPA/VAZKEPA franchise and reaffirm our commitment to advancing the science of cardiovascular care and addressing the very real issue of residual risk in patients worldwide. Cardiovascular disease continues to be the leading cause of death globally, and far too many high-risk patients are in urgent need of protection now. That is why we remain committed to raising awareness among healthcare providers, payers, and patients about the importance of using FDA-approved therapies for cardiovascular risk reduction, such as VASCEPA (icosapent ethyl)—proven to reduce cardiovascular events—on top of statin therapy in patients with elevated triglycerides,” said Steven Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin. “The updated FDA labeling for fibrates is a critical development for clinicians seeking to reduce residual risk in their patients. The recent label update for fibrates - prompted by a citizen petition led by HealthyWomen - now clearly states that fibrates do not reduce cardiovascular risk when used in combination with statins based on the neutral PROMINENT trial safety and efficacy data where a fibrate was added to statins in patients with diabetes who had high triglycerides and low HDL-C. The revised indication limits fibrate use only to reduce triglyceride levels in adults with severe hypertriglyceridemia or for LDL-C reduction in adults with primary hyperlipidemia when statin therapy is not possible. We must continue to reinforce the message that fibrates offer no added cardiovascular benefit over statins and the importance of treating patient outcomes.”