Europe approves Amgen’s new cholesterol-lowering drug Repatha
Biotech giant Amgen Inc. received the approval of European regulators for a new drug that the Thousand Oaks 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, Amgen said.
Repatha is an antibody that is injected into patients one or two times a month and can reduce low density lipoprotein, or LDL, by 50% or more.
“Repatha addresses the No. 1 killer of humans on the planet,” said Sean Harper, Amgen’s executive vice president of research and development. “We are excited to make this new cholesterol-lowering medication available for patients in Europe.”
Developed by Amgen’s scientists, 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, which have been the standard course of treatment for decades.
Amgen’s Repatha is part of a new class of drugs that block a substance that interferes with the liver’s ability to remove bad cholesterol.
The Food and Drug Administration is scheduled to make a decision on a similar drug from Sanofi and Regeneron Pharmaceuticals on Friday. The FDA is scheduled to review Amgen’s drug by Aug. 27.
Some analysts have estimated that the new class of medicine — including Repatha and drugs planned by other companies — could generate more than $10 billion in annual sales.
“I think that’s not an unreasonable expectation,” Harper said.
Questions remain about the new drugs’ price, which analysts said could exceed $10,000 or more per year in the United States. Amgen has not disclosed its pricing for Repatha.
The European approval was widely anticipated and did not appear to have much effect on Amgen’s stock, which fell 64 cents, less than 1%, to $163.70 on Tuesday.