Amarin gains added FDA indication for Vascepa

14 December 2019

Ahead of the regulator's expected action date of December 28, the US Food and Drug Administration on Friday approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels of 150 milligrams per deciliter or higher.

Vascepa is marketed by Ireland-incorporated Amarin Corp (Nasdaq: AMRN), whose shares jumped 10.74% to $26.71 in after-hours trading following the announcement, even though the labeling for Vascepa's use is more restrictive than what Amarin wanted. Amarin had asked for a label covering primary prevention for adults at risk of heart disease.

Amarin reaffirmed its intention to promptly launch Vascepa in the USA for this important new preventative care indication. As previously disclosed, Amarin doubled the size of its sales force near the beginning of 2019 and is on track to double the size of its sales force again to a total of 800 sales representatives near the beginning of 2020.

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