Amarin's lawyers were just in court last week suing the FDA for limiting the exclusivity it granted the drugmaker's fish oil pill Vascepa. But the Irish drugmaker hustled them back to court Tuesday, this time to sue AzstraZeneca, which is awaiting FDA approval on its own product for treating super-high cholesterol.
Amarin, which has faced a series of setbacks getting its fish oil pill to market, is lashing out at the FDA for some of its problems, Bloomberg reports.
Amarin's hopes of expanding the label for its omega-3 pill look even bleaker as the FDA has denied the company's appeal to reconsider its clinical data, sending shares down another 25% in premarket trading Tuesday.
Amarin's 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.
Amarin will have to wait until the new year to find out whether it's fish oil pill Vascepa will be approved for a wider indication.
Amarin's plodding effort to get Vascepa approved for a wider indication just got longer as the FDA delayed its final decision on the fish oil pill, but the company's backers are staying optimistic, and shares jumped as much as 20% on Friday morning.
Later this week the FDA is widely expected to turn its regulatory thumb down on Amarin's supplemental NDA for its prescription-strength fish oil pill Vascepa.
Already suffering from an expert panel rejection for an expanded label on its cholesterol drug Vascepa, Amarin was subjected to another drubbing on Wall Street after the FDA formally withdrew its Special Protocol Assessment agreement on a study of the treatment.
Amarin couldn't wait for the FDA's final decision on whether to grant its fish oil drug Vascepa approval for a wider use. With the handwriting on the wall, its stock price in the toilet and cash burning, the drugmaker said today that it will cleave half of its staff.
Shares of Amarin were blasted this morning--plunging 63%--as investors got a chance to vote with their money on the company's prospects following a decisive failure to persuade an FDA advisory committee that its fish-oil pill Vascepa should be approved for a much wider audience.