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Wednesday, Nov 29, 2023

FDA to Weigh Amgen’s Repatha

Health regulators have decided a new drug from Amgen Inc. reduces “bad” cholesterol, but they aren’t sure it’s for everyone.

The Food and Drug Administration released a review of the Thousand Oaks biotech’s drug Repatha on Monday in preparation for an advisory committee meeting on Wednesday. The FDA, which will vote later to approve or reject the drug for U.S. distribution, normally follows committee recommendations.

Repatha, also called evolocumab, is a new type of cholesterol treatment that blocks a chemical called PCSK9, which hinders the liver’s ability to remove cholesterol in the bloodstream. Cholesterol build-up inside arteries leads to heart disease, the leading cause of death in the United States.

Amgen has conducted clinical trials showing Repatha lowered cholesterol without an uptick in deaths or serious side effects in patients, but significant safety risks included pancreas and kidney problems.

And even though Repatha is a new type of drug, it already has competition. The advisory panel will consider another PCSK9 blocker on Tuesday from Sanofi, a French pharmaceutical company.

Amgen shares closed Monday down 78 cents, or a fraction of a percent, to $156.47 on the Nasdaq.

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