FDA Advisory Committee recommends Praluent (alirocumab) for treatment of Hypercholesterolemia- Sanofi + Regeneron

Sanofi and Regeneron Pharmaceuticals, Inc. announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA has recommended the approval of the investigational therapy Praluent (alirocumab) Injection for the treatment of hypercholesterolemia. The Committee voted 13 to three (with no abstentions) that Sanofi and Regeneron had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.

The Committee's recommendation was based on Praluent's benefit-risk profile, following review of efficacy and safety data from more than 5,000 patients across 10 pivotal Phase III double-blind trials ranging from six months to two years.The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015. The Marketing Authorization Application for Praluent in the European Union is currently under review.

Comment: Competitor Repatha (evolocumab) from Amgen was CHMP recommended for use in the EU in May 2015 for high cholesterol and rare disease heterozygous familial hypercholesterolaemia. The PDUFA date for Repatha in the US is 27 August.