Amarin’s fish-oil pill Vascepa failed to win the backing of U.S. advisers to significantly expand its use for those with high levels of fat in their blood.
Amarin should complete a study on the drug’s ability to benefit the heart before an approval decision for patients with high triglycerides, a Food and Drug Administration advisory panel voted 9-2 today in Silver Spring, Maryland. The FDA is scheduled to decide whether to clear the drug for wider use by Dec. 20. The agency doesn’t have to follow the panel’s advice.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat “very high” triglycerides, a measure of fat in the blood. Expanded approval would give Dublin-based Amarin access to 36 million potential U.S. customers who have elevated triglycerides, or nine times the pool of people with severely high levels. The company is seeking to treat high triglyceride patients on statin therapy who have low levels of good cholesterol and coronary heart disease.
“Let’s see the results in an outcomes trial,” Peter Wilson, a panel member and professor at Emory University’s School of Medicine in Atlanta, said during the meeting. “That’s really where the proof is, in the pudding, in my view.”
FDA staff questioned Oct. 11 whether Vascepa’s lipid-lowering effects were sufficient to move ahead with approval based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from the lipid lowering. Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, declined 20 percent Oct. 11 after the release of the staff’s report, the biggest one-day drop for the company’s American depositary receipts in more than three years. Trading was halted today during the panel’s meeting.
The FDA originally agreed with Amarin in 2008 that the company needed only to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides.
“The critical question which patients care about is, ultimately, will the observed changes in lipids/lipoproteins with Vascepa treatment in statin-treated patients translate into a benefit on cardiovascular outcomes,” Mary Roberts, a medical officer at FDA, said during the meeting. “This question is not new, but now we have more data.”
Amarin is studying Vascepa’s ability to reduce cardiovascular events, the results of which probably won’t be available until 2016, Steve Ketchum, president of research and development, said. Ketchum also said completing the study will cost Amarin “triple-digit millions of dollars.”
Sales of Vascepa, the company’s sole product, may reach $1.2 billion in 2017, according to the average of five analysts’ estimates compiled by Bloomberg. The company’s revenue is estimated to total $36 million this year.
GlaxoSmithKline Plc (GSK)’s fish oil pill Lovaza was approved in 2004 for patients with very high triglycerides. Very high triglyceride levels measure at least 500 milligrams per deciliter. High triglycerides are those from 200 milligrams to 500 milligrams per deciliter.
Stores such as GNC Holdings Inc. (GNC:US) and Vitamin Shoppe Inc. (VSI:US) sell non-prescription dietary supplements containing fish oil. It would take 10 to 40 of such omega-3 capsules to equal the pure fatty acid obtained from “wild deep-water Pacific Ocean fish,” according to the company’s website for Vascepa.
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