FDA Recommends Sanofi’s and Amgen’s Anti-Cholesterol Drugs
Sanofi and Regeneron Pharmaceuticals, Inc report that Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) has recommended the approval of the companies’ investigational anti-cholesterol drug, Praluent (alirocumab) injection. The committee voted 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 Advisory Committee’s recommendation will be considered by the FDA in its review of the biologics license application (BLA) for Praluent. The FDA is not bound by the committee’s recommendation, but takes its advice into consideration when reviewing investigational medicines. The BLA for Praluent was accepted for priority review by the FDA with a target action date of July 24, 2015.
If approved by the FDA, Praluent will be one of the first fully human monoclonal antibodies targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) in the US. The marketing authorization application for Praluent in the European Union is currently under review by the European Medicines Agency (EMA).
In addition to Sanofi, Amgen is seeking approval of its PCSK9 inhibitor as an anti-cholesterol drug, Repatha (evolocumab), which was also recommended for approval by the FDA’s EMDAC. The FDA has set of target action date of Aug. 27, 2015, for the Repatha BLA. In May 2015, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the marketing authorization of Repatha for use in certain patients with high cholesterol. The CHMP positive opinion is being reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
Pfizer also has a late-stage PCSK9 inhibitor, bococizumab, which is now in a Phase III clinical trial program.