Amarin's ($AMRN) regulatory fortunes haven't improved in the new year, as the FDA has again put off a decision on the company's fish oil pill for high cholesterol, indefinitely postponing a final approval on the troubled drug.
The company is working to expand the indications for its already-approved Vascepa, hoping to stretch the label from patients with dangerously high triglycerides to those with milder symptoms and thus expand the omega-3 pill's market. It first expected to hear a final word from the FDA back in December, but a procedural delay pushed that decision into 2014, and the latest setback won't help.
Amarin's regulatory bramble began in October, when the FDA revoked its support for the design of Vascepa's ANCHOR study, leading the company to file an appeal. The FDA told Amarin it would rule on the trial design by Jan. 15, but, with that date having come and gone, the agency is again delaying its decision, this time not providing a deadline. The FDA can't make a ruling on the proposed label expansion until it weighs in on ANCHOR, of course, so the latest setback only further postpones a final decision.
For its part, Amarin said it "does not expect the delay to be for a significant period of time," but the news sent the company's shares down about 8% on Thursday morning.
All of this back and forth could simply be window dressing for a future letdown, though. Amarin's hopes--and share value--largely deflated in the fall when an FDA advisory committee voted 9-2 against recommending the drug be approved for its intended patient population, suggesting the agency hold off until it gets a glimpse of the results of a clinical trial on coronary outcomes that won't wrap up until 2016.
That move sent Amarin's shares down more than 60%, spurring the company to slash its payroll and likely spelling the demise of CEO Joe Zakrzewski, who called it quits on Jan. 1.
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