“Let’s see the results in an outcomes trial,” Peter Wilson, a panel member and professor at Emory University’s School of Medicine in Atlanta, said during the meeting. “That’s really where the proof is, in the pudding, in my view.”
FDA Staff
FDA staff questioned Oct. 11 whether Vascepa’s lipid-lowering effects were sufficient to move ahead with approval based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from the lipid lowering. Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, declined 20 percent Oct. 11 after the release of the staff’s report, the biggest one-day drop for the company’s American depositary receipts in more than three years. Trading was halted today during the panel’s meeting.
The FDA originally agreed with Amarin in 2008 that the company needed only to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides.
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