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FDA Panel Gives Evolocumab Green Light, With Advice on Who Gets It to Follow


FDA's advisory panel voted 11-4 to give the green light to Amgen's entrant in the PCSK9 inhibitor race, but not after a lengthy discussion on who should get the drug.

An FDA advisory panel voted 11-4 Wednesday to recommend approval for Amgen’s PCSK9 evolocumab, but not without a lengthy discussion of which patients would be eligible to receive the drug. More advice on those terms is expected.

Similar caveats were seen in Tuesday’s 13-3 advisory panel vote to recommend alirocumab, from Sanofi-Regeneron. Both PCSK9 inhibitors facing deadlines this summer for FDA action.

The advisory panel votes have the potential to take huge markets for the drug off the table. But for anyone following editorials in leading journals, the ambivalence shouldn’t have come as a surprise.

FDA’s 16-member Endocrinologic and Metabolic Drugs Advisory Committee (which changed slightly from Tuesday to Wednesday) only had to find that the drugs’ manufacturers had established that the LDL cholesterol—lowering benefit for certain populations. But who those populations will be was the subject of much debate. After Tuesday’s discussion, Amgen brought in Marc Sabatine, MD, who had presented results on evolocumab at the recent meeting of the American College of Cardiology on why patients who cannot tolerate statins should have access to the therapy.

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