EMA’s CHMP Recommends Sanofi’s Anti-Cholesterol Drug

The European Medicine Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of Sanofi’s and Regeneron Pharmaceuticals, Inc.’s Praluent (alirocumab), recommending its approval for use in certain adult patients with hypercholesterolemia. Praluent is an investigational fully human monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9).

The European Commission (EC) is expected to make a final decision on the marketing authorization application for Praluent in the European Union in late September. Regeneron/Sanofi recently received a recommendation for approval by a FDA advisory committee for Praluent.The BLA for Praluent was accepted for priority review by the US Food and Drug Administration (FDA) with a target action date of July 24, 2015; the FDA approved the drug on July 24, 2015. 

Sanofi/Regeneron are in a competition to market for its PCSK9 inhibitor with Amgen and its PCSK9 inhibitor, Repatha (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, which was approved by the European Commission earlier this week for treating uncontrolled cholesterol in patients that require additional intensive low-density lipoprotein cholesterol (LDL-C) reduction. Repatha is a human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver’s ability to remove LDL-C, or “bad” cholesterol, from the blood.

The EC approval or Repatha marked the first regulatory approval for a PCSK9 inhibitor, a potential blockbluster class of drugs, for treating cholesterol. Repatha is under regulatory review by the FDA with a target action date of August 27, 2015. Amgen is partnered with Astellas Pharma for Repatha in Japan as part of a multi-drug collaboration the companies formed in 2013. The long-term collaboration focuses on the co-development and co-commercialization in Japan of five Amgen pipeline medicines (which included the now approved Repatha). and also created a Tokyo-based joint venture company, Amgen Astellas BioPharma KK. Sanofi/Regeneron Pharmaceuticals also have a PCKS9 inhibitor under regulatory review and Pfizer has a drug in late-stage development.

A a recent Thomson Reuters analysis pegs both drugs as potential blockbusters. Based on estimates for 2019 sales, the analysis puts potential revenues at Regeneron Pharmaceuticals and Sanofi's Praluent (alirocumab) at $4.4 billion, and Amgen's/Astellas’ evolocumab at nearly $1.9 billion by 2019. Pfizer also has a late-stage PCSK9 inhibitor, bococizumab, which is now in a Phase III clinical trial program.

Source: Sanofi (EMA’s CHMP recommendation) and Sanofi (FDA approval)

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