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news.The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for Sanofi and Regeneron's Praluent (alirocumab), which is designed to treat patients with hypercholesterolemia.
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Alirocumab is an investigational monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).
Under the Prescription Drug User Fee Act (PDUFA), the goal for a priority review is six months, for a target action date of 24 July 2015.
The BLA was based on data from more than 5,000 patients, including ten Phase III ODYSSEY trials.
Along with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include over 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to about five years.
Earlier in January, the European Medicines Agency (EMA) accepted to review the marketing authorization application (MAA) for Praluent in the European Union (EU).
Both EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab.
Currently, the safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
Image: Both EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. Photo: courtesy of Baitong333/ FreeDigitalPhotos.net.