Amarin's Vascepa Gets ADA Recommendation For Patients With Diabetes And High Triglycerides
The company has racked up a lot of wins for its proprietary fish oil derivative based on the REDUCE-IT study, the latest being inclusion in diabetes treatment guidelines. Amarin also has now submitted a supplemental NDA seeking a label update reflecting the outcomes trial results.
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Amarin won't seek approval in the EU until later this year, but doctors there are encouraged to consider Vascepa for patients with high triglycerides despite statin therapy. Also, PCSK9 inhibitor guidelines were solidified for very high risk patients.
The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.
Anticipating a label expansion this fall based on the REDUCE-IT cardiovascular outcomes study, Amarin will double its sales force and has raised revenue guidance. Approved to reduce very high triglyceride levels, Vascepa sales total $170m-$174m so far this year.