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Marketing application for alirocumab accepted by EMA for review

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A Marketing Authorization Application for Regeneron and Sanofi’s alirocumab for the treatment of hypercholesterolemia has been accepted by the European Medicines Agency, according to a press release.

Alirocumab (Praleuent, Regeneron and Sanofi) is an investigational monoclonal antibody that targets proprotein convertase subtilisin/kexin type 9 (PCSK9).

The application includes data from >5,000 patients, including 10 phase 3 ODYSSEY trials. More than 23,500 patients from over 2,000 study centers are expected to participate in double-blind, randomized placebo-and-active-controlled trials from 24 weeks to 5 years in the ODYSSEY clinical trial program and other ongoing studies.

The FDA received the biologics license application in the fourth quarter of 2014.