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Label expansion of Amarin's Vascepa has unanimous backing of FDA advisory panel

Published on 15/11/19 at 12:13pm

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favour of expanding the existing approval of Irish firm Amarin’s Vascepa (icosapent ethyl) to cover the the reduction of cardiovascular events in high-risk patients.

The advisory panel voted unanimously in favour of the motion – all 16 votes for – presenting a compelling argument for the US agency when it comes to making its final decision. While the FDA is not bound by the ruling, it very often takes committee decisions to heart and eventually mirrors its judgement.

Data submitted to the committee was derived from a study of 8,179 participants across 400 clinical sites in 11 countries over seven years.

“The REDUCE-IT results are quite remarkable and illustrate how icosapent ethyl could transform the treatment of cardiovascular disease in the United States and worldwide,” remarked Dr Deepak L Bhatt, Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital Heart and Vascular Center, and Professor of Medicine at Harvard Medical School. “From my perspective as not only a researcher but also a practicing physician, icosapent ethyl represents one of the most important developments in the prevention and treatment of cardiovascular disease since statins and, if FDA approved, will be a critical tool for physicians to use to help prevent cardiovascular events such as heart attack and stroke, including fatal ones, in high-risk patients.”

Amarin President and CEO John F Thero also commented: “Today we moved an important step closer to potentially helping millions of patients who are at risk for cardiovascular events despite being on standard-of-care statin therapy. Vascepa is positioned to be the first approved treatment to reduce cardiovascular events in the group of at-risk patients studied in the landmark REDUCE-IT clinical trial. We appreciate both the opportunity to present these results and the committee’s strong vote of confidence. We look forward to anticipated labelling discussions with the FDA, and we continue to prepare for the launch of Vascepa assuming FDA approval of our sNDA on or before the target PDUFA date of 28 December.”

Matt Fellows

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