US advisers endorse PCSK9 Praluent, but limited population

Jun 10 2015

• By Donna Young

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Not wanting to withhold a new type of cholesterol-lowering drug for two years from desperate patients while waiting for cardiovascular outcomes trial (CVOT) data, a panel of experts on 9 June supported Sanofi and Regeneron Pharmaceuticals putting their proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Praluent (alirocumab) on the US market, despite fears that an FDA approval could mean the large study testing the medicine's ability to prevent heart attacks may be abandoned.

Not wanting to withhold a new type of cholesterol-lowering drug for two years from desperate patients while waiting for cardiovascular outcomes trial (CVOT) data, a panel of experts on 9 June supported Sanofi and Regeneron Pharmaceuticals putting their proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor Praluent (alirocumab) on the US market, despite fears that an FDA approval could mean the large study testing the medicine's ability to prevent heart attacks may be abandoned.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 13-3 that Sanofi and Regeneron had sufficiently established that the...

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