LOS ANGELES - Biotech giant Amgen Inc. received the approval of European regulators for a new drug the company said is highly effective at reducing “bad” cholesterol, which is a significant risk factor for heart disease.
The European Commission’s approval of the drug Repatha creates an important new option for patients who had not been able to reduce cholesterol with existing medications, said the company, based in Thousand Oaks, Calif.
Repatha is an antibody that is injected one or two times per month and can reduce low density lipoprotein, or LDL, by 50 percent or more.
Repatha is the first in a new class of medications that help the liver more effectively remove bad cholesterol from the blood. The drug has proved more effective at lowering cholesterol than statins.
The Food and Drug Administration is set to rule on a similar drug from Sanofi and Regeneron Pharmaceuticals on Friday. The FDA will review Amgen’s drug by Aug. 27.
Some analysts estimate that the new class of medicine — including Repatha and others — could generate more than $10 billion in annual sales.
Questions remain about the new drugs’ price, which analysts said could exceed $10,000 or more per year in the U.S.