The European Commission has authorized Amgen Inc. to sell its anti-cholesterol drug Repatha, the company announced Tuesday.
The Thousand Oaks biotech’s drug is the first in a new class of cholesterol treatments called PCSK9 inhibitors. The injectable Repatha, also known as evolocumab, helps the liver remove “bad” cholesterol from the bloodstream. The EU authorized Repatha for use in adults with a genetic disposition to high cholesterol, and those who do not respond to statins, the conventional cholesterol treatment.
A panel at the Food and Drug Administration has recommended approval of Repatha in the U.S. market, and the agency is expected to make a decision later this year.
Repatha already has competition. Praluent, a drug developed by Regeneron Pharmaceuticals Inc. in Tarrytown, N.Y. and Paris-based Sanofi, is awaiting regulatory approval.
Amgen shares closed down 64 cents or a fraction of a percent to $163.70 on the Nasdaq.