Amarin Corporation plc AMRN shares were halted for trading Thursday morning pending an announcement of the Adcom verdict on the label expansion it is seeking for its fish oil pill Vascepa.
Amarin shares have been on a tear this week, with the stock gaining about 24% Tuesday in reaction to the briefing document released ahead of the FDA panel decision.
Incidentally, the stock lost roughly 17% Aug. 9 in reaction to the company's disclosure of an FDA communication regarding the convening of the Adcom meeting.
What's An Adcom Meeting?
An advisory committee is convened by the FDA to provide it with independent advice on issues related to drugs, vaccines, biological products, devices and food.
The FDA has 31 advisory committees.
An Adcom meeting is announced only if the FDA has significant concerns or questions regarding the clinical data submitted along with the regulatory application.
An Adcom comprises mostly physicians and scientists whose specialties or research are related to the product being reviewed. Other members could be specialists such as statisticians, epidemiologists, nutritionists or toxicologists.
Almost all committees have representation from the industry and consumers. The size of the committee typically ranges from 10 to 15 members.
At the end of the meeting, most members vote on questions posed to them, although they may also choose to abstain from voting. The FDA considers the deliberations and contributions to the discussion as important rather than the final vote.
Although the FDA will consider a panel's recommendation, is not bound by the decision.
Amarin's Adcom Meeting
FDA's Endocrinologic and Metabolic Drugs Advisory Committee commenced a meeting at 8 a.m. Thursday to discuss Amarin's sNDA for Vascepa for reducing the risk of cardiovascular events as an adjunct to statin therapy in adult patients with elevated triglycerides levels and other risk factors for cardiovascular disease.
At 5 p.m. ET, Amarin announced the committee voted unanimously (16-0) to recommend approval of an indication and label expansion for Vascepa.
Vascepa was previously approved in 2012 as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.
The briefing document released Tuesday ahead of the panel vote showed deliberations in line with expectations. FDA staffers seemed convinced that the REDUCE-IT trial provided robust and consistent evidence for cardiovascular risk reduction.
The FDA is set to rule on the Vascepa sNDA on Dec. 28.
Related Links:
Amarin Shares Climb Following In-Line Review Of Fish Oil Pill By FDA Staffers
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