FDA Update on Fenofibrate Opens Door for New Cardiovascular Treatments
The U.S. Food and Drug Administration (FDA) has updated the labeling for fenofibrate products, now acknowledging the lack of cardiovascular benefit when used alongside statins. This development has sparked reactions from experts in the field, including Dr. Steven Ketchum of Amarin Corporation plc, who sees it as a critical moment for clinicians seeking to reduce residual risk in their patients.
Dr. Ketchum, Ph.D., EVP, President of R&D, and Chief Scientific Officer at Amarin, welcomed the updated FDA labeling, stating that it highlights the need for alternative treatments to manage cardiovascular disease risk. Meanwhile, Dr. Deepak L. Bhatt, Director of the Mount Sinai Fuster Heart Hospital in New York, supported the role of icosapent ethyl (IPE) in comprehensive cardiovascular risk management, citing recent post hoc analyses of the REDUCE-IT® trial.
IPE, the active ingredient in VASCEPA®/VAZKEPA® capsules, has shown to provide cardiovascular protection beyond standard therapy with statins and aspirin, without additional safety concerns. Amarin Corporation plc's new post hoc analysis of aspirin use in REDUCE-IT® further reinforces this, demonstrating a 28% reduction in primary endpoint events among aspirin users (P<0.0001). In the secondary prevention cohort, this reduction was even more significant, at 39% (P<0.0001). The safety profile of IPE in aspirin users was consistent with the overall study population, indicating its potential as a valuable addition to standard care for cardiovascular disease.
The updated FDA labeling for fenofibrate products has opened the door for alternative treatments in cardiovascular disease risk management. With the consistent benefits and safety profile of icosapent ethyl in both aspirin users and non-users, clinicians now have a valuable option to address residual cardiovascular disease risk in patients. Amarin Corporation plc remains committed to advancing the science of cardiovascular care worldwide.
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