$REGN Analyst Blog

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Regeneron/Sanofi’s PCSK9 Drug Praluent Set for FDA Panel – Analyst Blog

Regeneron Pharmaceuticals, Inc. REGN and its partner Sanofi’s SNY PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody, Praluent, is set to face the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Jun 9, 2015. The FDA released briefing documents ahead of the advisory committee’s meeting.

While Regeneron was up 4%, reaching a new 52-week high, Sanofi was down 2.6% on the news.

Regeneron and Sanofi are looking to get the candidate approved for the treatment of patients suffering from hypercholesterolemia. We remind investors that Regeneron and Sanofi had earlier announced that the regulatory application for Praluent was accepted for priority review by the FDA. The FDA is expected to render a final decision by Jul 24, 2015. Meanwhile, the European Medicines Agency has also accepted the marketing authorization application for Praluent.

The panel is expected to conduct a risk-benefit analysis of Praluent and also discuss if the candidate has sufficiently established its low-density lipoprotein cholesterol (LDL-C) lowering benefits. The panel will also deliberate on whether Praluent exceeds its risks to support approval in one or more patient populations.

We remind investors that Amgen AMGN is also seeking FDA approval for its PCSK9 inhibitor, Repatha. Repatha is currently under review both in the U.S. and EU. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will review the candidate on Jun 10, 2015.

We note that several other companies are also developing their own PCSK9 inhibitors.

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