Vascepa ist best in class und wird sich auf kurz oder lang durchsetzen:
Amarin Says U.S. Ruling on Fish Oil Pill Delayed on Trial
By Anna Edney Dec 20, 2013 12:56 PM GMT+0100 - Comments Email Print
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Amarin Corp. (AMRN) said the Food and Drug Administration delayed ruling on expanded use of its fish-oil pill while the regulator considers the drugmaker’s appeal of a decision requiring a clinical trial showing whether the product improves cardiovascular outcomes.
A decision scheduled for today was postponed indefinitely as the FDA looks at Amarin’s request, the Dublin-based drugmaker said today in a statement.
The FDA approved the prescription-grade omega-3 fatty acid last year to treat severe triglycerides, a measure of fat in the blood. Expanding use of the pill, Amarin’s only product, to less seriously ill patients who have elevated triglycerides would give the drugmaker access to 36 million U.S. customers, or nine times the pool of people with very high levels.
The pill, Vascepa, may generate $28 million in sales this year, according to the average of six analysts’ estimates compiled by Bloomberg.
Amarin said on Dec. 16 that John Thero, the company’s current president, will become chief effective officer on Jan. 1, succeeding Joseph Zakrzewksi, who will retire.
The FDA agreed with Amarin in 2008 that the company needed to have the cardiovascular outcomes trial under way, not completed, when it sought approval for people with high triglycerides. The agency rescinded the accord Oct. 29 based on recent clinical trials and meta-analyses that have failed to confirm a heart benefit from lowering lipids.
Appeal Ruling
Amarin said today that the FDA will relay its decision on the appeal by Jan. 15. The regulator hasn’t indicated when it will rule on the application to expand use of the drug, the company said.
Triglycerides and cholesterol are separate types of lipids, or fat in the blood, according to the Mayo Clinic.
Amarin, run from Bedminster, New Jersey, sought approval for the drug to treat patients with high triglycerides who also are taking cholesterol-lowering statins.
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) and Vitamin Shoppe Inc. (VSI) 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.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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