FDA Approval Of Second PCSK9 Inhibitor Expected Soon

The FDA has until Thursday, August 27 to make its decision about Repatha (evolocumab), Amgen’s much anticipated cholesterol lowering PCSK9 inhibitor. The drug is widely expected to gain approval. Last month the FDA approved Praluent (alirocumab), Sanofi’s and Regeneron’s similar drug. Beyond approval the major questions that should be answered this week concern the drug’s label and the drug’s price.

The approved indication for Praluent was broader than some had expected. The FDA approved Praluent for use in patients with heterozygous familial hypercholesterolemia (HeFH) already taking maximally tolerated statins and for secondary prevention in patients with established cardiovascular disease who require additional LDL lowering. The general expectation is that the Repatha label will be similar. But there are rumors on Wall Street that Repatha might receive a primary prevention indication, but I agree with Forbes reporter Matthew Herper who tweeted that he’d “be shocked if this happens.”

Price is the other big remaining question. The list price for Praluent is $14,600 a year. Echoing others, Andrew Pollack writes in the New York Times that “insurers hope competition will lower costs.” Insurers are also likely to raise barriers before providing reimbursement, including documentation that patients qualify for PCSK9s by proving that they are taking maximally tolerated statins, for instance.





  1. jasonweinstock says

    It is amazing the level of hype surrounding this class of drugs when there is no proof they improve outcomes and the side effect profile is ambiguous at best. the esperion therapeutics drug is more promising.

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