Analysts expect new approval for Amarin's Vascepa

Analysts say they think FDA will expand approval of Amarin drug; shares fell 20 pct Friday

Associated Press

NEW YORK (AP) -- Analysts said Monday that regulators will probably grant a broader marketing approval for Amarin's triglyceride drug Vascepa.

THE OPINION: Analysts including Jonathan Eckard of Citi Investment Research and Ritu Baral of Canaccord Genuity said they think the FDA will the new grant approval by the December deadline.

"We continue to view Vascepa's very clean safety profile (will) allow the FDA to approve the drug in this new setting prior to the availability of outcomes data from the ongoing REDUCE-IT trial in 2015-16," Eckard said.

A panel of Food and Drug Administration advisers is scheduled to review Vascepa, a fish oil drug, on Wednesday. The panel's initial views and questions about the drug were posted online Friday, and they included questions about whether that would result in real health benefits. Shares of Amarin plunged 20 percent Friday.

Vascepa was approved in 2012 for patients with unusually high triglyceride levels, but Amarin wants to get a broader marketing approval. It is asking the FDA to allow it to market the drug for patients with high triglyceride levels and heart disease who are already taking a statin drug to try and control their cholesterol. That would help increase sales.

The FDA is scheduled to make a ruling on Vascepa by Dec. 20. However Amarin is conducting a study of the drug's cardiovascular effects, and results won't be available for several years. It's possible the FDA won't approve the drug until data from that trial is available.

THE STOCK: Amarin Corp. plc shares gained 10 cents to $5.18 in afternoon trading. The stock is down 37 percent in the year to date.

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