EMA/CHMP positive opinion for Praluent as treatment for hypercholesterolemia

24 July 2015

The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the marketing authorization of 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) developed and to be marketed by Regeneron Pharmaceuticals (Nasdaq: REGN) and partner French pharma major Sanofi (Euronext: SAN).

"We are very pleased to receive a positive opinion from the CHMP for Praluent, and look forward to bringing Praluent to those in greatest need across Europe," said Elias Zerhouni, president, global R&D, Sanofi, adding; "Despite statins and other lipid-lowering therapies, many patients are unable to reach their LDL cholesterol goals, and may benefit from new therapeutic options such as Praluent."

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