The ADA is a non-profit organization that works to spread awareness about diabetes, besides raising funds for researches taking place in this field. As a general policy, the organization does not endorse or certify any specific brands.
ADA’s findings relate to icosapent ethyl, which Amarin markets under the brand name Vascepa capsules. Vascepa has received FDA approval to cut down triglyceride levels in adult patients. The Dublin, Ireland-based firm has, meanwhile, commenced transmission of data to the FDA seeking an expansion of the Vascepa FDA label based on the landmark REDUCE-IT results.
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The FDA is yet to review this application, but investors are hoping that ADA’s reference would now help fast-track the process.
In the Standard of Care recommendation, ADA notes, “…based on the outcome of Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial (REDUCE-IT), which determined the addition of icosapent ethyl to statin therapy for patients with high triglyceride levels reduced cardiovascular events.”
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Meanwhile, it also added, “It should be noted that data are lacking with other omega-3 fatty acids, and results of the REDUCE-IT trial should not be extrapolated to other products.”
Earlier last month, shares of Amarin Corp rallied 14% on rumors that Novartis (NVS) is looking to buy the Dublin-based firm. There have been no further updates on the same.
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