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FDA Approves Amgen Cholesterol Drug Repatha

Amgen Inc. has received approval to market its cholesterol drug Repatha in the United States, the company announced late Thursday. The Thousand Oaks biotech plans to start selling the injectable treatment next week. Repatha is one of a new class of cholesterol treatments called PCSK9 inhibitors that help the liver remove “bad” cholesterol from the bloodstream. Repatha will be available as a single-use prefilled auto-injector or syringe that patients can self-administer. Each syringe will contain 140 milligrams, the recommended dose every two weeks. Amgen will sell each syringe at a wholesale price of $542.31, or $14,100 annually if administered every two weeks. However, the company said actual costs to patients, payers and health systems are anticipated to be lower as the pricing does not include discounts or rebates. “Amgen is sensitive to the concerns of payers around cost, budget predictability and paying for value,” Anthony Hooper, executive vice president of global commercial operations, said in a statement. “We are confident in the ability of Repatha to demonstrate real-world effectiveness and value.” Marketing authorization for Repatha in Europe was announced in July. Shares closed Friday up 17 or a fraction of a percent to $155.89 on the Nasdaq.

Joel Russel
Joel Russel
Joel Russell joined the Los Angeles Business Journal in 2006 as a reporter. He transferred to sister publication San Fernando Valley Business Journal in 2012 as managing editor. Since he assumed the position of editor in 2015, the Business Journal has been recognized four times as the best small-circulation tabloid business publication in the country by the Alliance of Area Business Publishers. Previously, he worked as senior editor at Hispanic Business magazine and editor of Business Mexico.

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