Amarin Builds Sales Infrastructure For EU Vazkepa Launch
CHMP Positive Opinion At January Meeting
With an approval nod from the EMA’s scientific committee for its fish oil product Vazkepa, launch plans for the EU for this “multi-billion dollar” opportunity are on track, says Amarin CEO.
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A Federal Circuit panel affirmed a district court decision in favor of two generics makers, but Amarin will seek a hearing from the full 12-member appellate court. Vascepa marketing is unchanged for now.
While its NDA languishes at the US Food and Drug Administration, the EMA’s CHMP has said yes to dostarlimab’s marketing in the EU for endometrial cancer.