FDA Advisory Panel Votes for Sanofi's PCSK9 Inhibitor, but Adds Caution

Developed jointly by Sanofi and Regeneron, alirocumab (Praluent) was approved 13-3 by an FDA advisory committee for the long-term treatment of adult patients with primary hypercholesterolemia or mixed dyslipidemia, including patients with type 2 diabetes mellitus.

However, several committee members warned about the cardiovascular (CV) effects of the drug, and discussions included whether low-density lipoprotein was indeed an appropriate surrogate for CV outcomes. The deputy director of the FDA's Division of Metabolism and Endocrinology, cautioned that if a decision was made to approve the drug, the agency would not require further assessments of cardiovascular outcomes. He therefore asked the panel to identify the population for whom the apparent cholesterol-lowering benefits of alirocumab could substitute for demonstrated clinical outcomes.

Alirocumab is being evaluated in a CV outcomes trial, with an expected completion date in 2017. However, if the drug was approved, panelists think patients would withdraw from the trial.

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