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FDA division won't reinstate SPA for Amarin's Vascepa
The FDA's Division of Metabolism & Endocrinology Products has told Amarin (
AMRN) that it doesn't plan to reinstate a special protocol assessment
agreement (SPA) for a trial related to the expanded use of the
biopharmaceutical firm's Vascepa drug.Amarin intends to appeal the decision
to the FDA's director of the Office of Drug Evaluation II.The FDA had
originally allowed the SPA, but rescinded it in October, saying that it
would no longer consider a change in serum triglyceride levels as enough
evidence to show efficacy.Under the new "ANCHOR" indication, the therapy
would be used to treat people who take statins to cut cholesterol and have a
high risk of coronary heart disease.Shares plummet 26%. (PR)
The FDA's Division of Metabolism & Endocrinology Products has told Amarin (
AMRN) that it doesn't plan to reinstate a special protocol assessment
agreement (SPA) for a trial related to the expanded use of the
biopharmaceutical firm's Vascepa drug.Amarin intends to appeal the decision
to the FDA's director of the Office of Drug Evaluation II.The FDA had
originally allowed the SPA, but rescinded it in October, saying that it
would no longer consider a change in serum triglyceride levels as enough
evidence to show efficacy.Under the new "ANCHOR" indication, the therapy
would be used to treat people who take statins to cut cholesterol and have a
high risk of coronary heart disease.Shares plummet 26%. (PR)