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FDA To Hold Advisory Committee Hearing For Amarin's Vascepa SNDA, Stock Fall 22%

Amarin Corp. (AMRN) Thursday announced that the U.S. FDA has scheduled an advisory committee meeting for November 14 in connection with its review of the pending supplemental new drug application for expansion of Vascepa.

The agency's deadline for making an approval decision on the heart drug will also likely be extended into late December from September 28, the company said.

The supplemental new drug application for Vascepa seeks cardiovascular risk reduction indication. The company is also planning to submit an application seeking approval for Vascepa in Europe before the end of 2019.

Last month, Amarin had said that FDA is "unlikely" to convene an advisory committee meeting to review data on an expanded use of its heart drug Vascepa.

Amarin generated revenues of $100 million in the second quarter of 2019, which is a record for Vascepa sales. The drug generated revenue of $52.6 million in the second quarter of 2018.

Vascepa is a prescription-only omega-3 fatty acid capsule, used as an adjunct to diet for reducing triglyceride levels in adult patients with severe hypertriglyceridemia.

"We look forward to the planned advisory committee meeting as an opportunity to highlight the landmark REDUCE-IT data and the important role we expect Vascepa should play in the treatment of cardiovascular disease in appropriate patients," stated John Thero, president and chief executive officer of Amarin.

AMRN closed Thursday's trading at $17.81, up $0.95 or 5.63%, on the Nasdaq. The stock, however, slipped $4.02 or 22.57% in the after-hours trade.

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