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FDA accepts alirocumab for priority review

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Sanofi and Regeneron announced that the FDA has accepted the companies’ Biologics License Application for the proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab for priority review.

According to a press release, under the Prescription Drug User Fee Act, the goal for a priority review is 6 months, and the agency has a target action date of July 24, 2015.

Alirocumab, an investigational monoclonal antibody targeting PCSK9, is intended for the treatment of hypercholesterolemia. The European Medicines Agency accepted alirocumab for review earlier in January. Both the FDA and the EMA have conditionally accepted Praluent as the brand name for alirocumab should it be approved, according to the release.

The BLA for alirocumab includes data collected from more than 5,000 patients, including those in 10 phase 3 ODYSSEY trials. With ongoing studies, such as ODYSSEY OUTCOMES, factored in, the ODYSSEY program will include the study of more than 23,500 patients for up to approximately 5 years, according to the release.

In July, Sanofi and Regeneron announced that they had purchased a priority review voucher from BioMarin GALNS Ltd. for $67.5 million. The purchase means that alirocumab could be approved by the FDA before Amgen’s PCSK9 inhibitor evolocumab despite its BLA having been filed later: Amgen announced in November that the BLA for evolocumab had been accepted for review by the FDA, with a PDUFA target action date of Aug. 27, 2015.