Amarin Gains On FDA Approval Of Vascepa Label Expansion
Zacks Investment Research | Dec 15, 2019 08:38PM ET
Shares of Amarin Corporation (NASDAQ:AMRN) gained after the company announced that the FDA approved a label expansion for Vascepa.
Vascepa is now approved as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.
The approval was based on the results of the REDUCE-IT cardiovascular outcomes study. Last month, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted unanimously (16-0) to approve the label expansion for Vascepa (icosapent ethyl) capsules to reduce cardiovascular risk in patients with persistent elevated triglycerides on statin therapy for LDL-C (bad cholesterol).
The label expansion should significantly boost Vascepa as, per estimates, millions of high-risk patients in the United States could benefit from this one-of-a-kind prescription therapy. Vascepa will be a new FDA-approved treatment option to reduce the persistent cardiovascular risk faced by many patients despite the use of statins with other contemporary standard-of-care therapies.
We remind investors that the drug was initially approved by the FDA as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
Amarin will launch the drug in the United States immediately, given its strong sales force, which it had doubled toward the beginning of 2019. It will double the size of its sales force again to a total of 800 sales representatives in the beginning of 2020. We expect the initial uptake of the drug to be strong and boost the top line, given the market potential.
Shares of Amarin have soared 77.2% so far this year compared with the Original post
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