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Amgen's Repatha lowers LDL, no marked safety events-FDA staff
June 8, 2015 / 12:32 PM / 2 years ago

Amgen's Repatha lowers LDL, no marked safety events-FDA staff

WASHINGTON, June 8 (Reuters) - Amgen Inc's experimental drug Repatha lowers cholesterol and there were no marked disparities in deaths or serious adverse events, according to a preliminary review Monday by the U.S. Food and Drug Administration.

The review comes before a meeting on Wednesday of outside advisers to the agency who will discuss the drug and recommend whether it should be approved.

The agency asked the panel to consider whether dosing options for the drug allow sufficient flexibility to healthcare providers. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

Repatha is one of a new class of cholesterol-lowering drugs known as PCSK9 inhibitors. Another drug in the class, Praluent, made by SAnofi SA and Regeneron Pharmaceuticals Inc will be considered by the panel on Tuesday. (Reporting by Toni Clarke in Washington)

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