FDA deals Amarin a setback on cholesterol drug

The U.S. Food and Drug Administration has notified Amarin Corp. plc that it does not intend to reinstate an agreement investors had counted on to boost the market for the company's cholesterol drug Vascepa.

Amarin's acknowledgment of the decision by the FDA's Division of Metabolism and Endocrinology Products sent the company stock price plummeting by 25 percent in early trading Tuesday, leaving shares 75 percent lower than they were just three months ago. At the end of the day, Amarin's share price on the Nasdaq exchange was $1.73, down 54 cents.

Amarin, an Irish company with research headquarters in Groton, said it would appeal the decision to the director level within the FDA.

"The FDA has indefinitely postponed a final ruling on Vascepa, initially expecting to weigh in by Dec. 20 but now pushing that date back to allow for Amarin's spiraling appeal process," according to a posting on the industry blog FiercePharma.

The FDA had granted Amarin a special protocol assessment agreement that appeared to clear the way for quick approval of Vascepa in conjunction with heart drugs such as Lipitor, targeting an expanded group of patients with moderately elevated levels of the blood fat known as triglycerides. Vascepa already has FDA clearance for use in patients with extremely high triglyceride levels, which is a biomarker for heart problems.

But the FDA last year rescinded the agreement, saying that it did not have enough evidence to determine whether lowering high triglyceride levels resulted in patients enjoying fewer risks of serious problems such as heart attacks. An FDA panel had earlier voted 9-2 against approving Vascepa labeling that would allow marketing to patients with moderately elevated triglycerides.

The FDA is not expected to make a final ruling on Amarin's so-called supplemental new drug application until it comes to a final resolution of the dispute over the agency's decision to rescind its special protocol agreement. If Amarin loses its next round at the director level, it has two other avenues of appeal within the FDA.



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