Amarin scored a victory. Now we can fight over the margin
Yesterday’s much-watched FDA discussion of Amarin’s heart drug went the company’s way: The assembled experts voted unanimously to expand the use of Vascepa.
But, as STAT’s Adam Feuerstein and Matthew Herper noted, there’s still plenty to debate. Amarin wants as wide a label as possible, one that recommends Vascepa even for patients at low risk for heart attack. But the FDA’s advisers seemed skeptical of that idea, more convinced of Vascepa’s benefits for patients who have already had a heart attack or stroke.
The meeting leaves no question that Vascepa will get an expanded label, but the scope of that expansion will determine whether Amarin’s drug is a $1 billion product or a $10 billion product.
Read more.
But, as STAT’s Adam Feuerstein and Matthew Herper noted, there’s still plenty to debate. Amarin wants as wide a label as possible, one that recommends Vascepa even for patients at low risk for heart attack. But the FDA’s advisers seemed skeptical of that idea, more convinced of Vascepa’s benefits for patients who have already had a heart attack or stroke.
The meeting leaves no question that Vascepa will get an expanded label, but the scope of that expansion will determine whether Amarin’s drug is a $1 billion product or a $10 billion product.
Read more.
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