FDA Approves New Amgen Cholesterol Drug

The Food and Drug Administration approved a new Amgen Inc. cholesterol-lowering drug on Thursday, teeing up a rivalry with a similar treatment that was approved just weeks earlier.

The Amgen therapy, Repatha, belongs to a powerful new drug class that promises help for patients who have struggled to control their cholesterol using older statin medicines. In July, the FDA approved the first drug of this new class, Praluent, from Sanofi SA and Regeneron Pharmaceuticals Inc.

Doctors and patients have been looking forward to these new cholesterol-lowering agents, which are injections either monthly or every two weeks. Some 11 million people in the U.S. can't lower their so-called bad cholesterol, LDLs, to healthy levels using statins pills like Lipitor and Crestor, according to Amgen.

"Many patients who are in a state where they cannot get to an acceptable LDL level will benefit," Amgen R&D chief Sean Harper said.

Yet health insurers and drug-benefit managers have expressed concerns about the new drugs' cost. Analysts say the new drug class could reach yearly sales of $10 billion world-wide.

As it did with Praluent, the FDA approved Repatha for use, in addition to statin drugs, in patients with a hereditary condition called familial hypercholesterolemia or with coronary-artery disease that requires additional lowering of cholesterol.

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(END) Dow Jones Newswires

August 27, 2015 19:05 ET (23:05 GMT)

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