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The potential blockbuster treatment targets a protein involved in cholesterol homeostasis.
Praluent (alirocumab), Sanofi and Regeneron’s investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) for the treatment of hypercholesterolemia, was granted Priority Review by FDA on Jan. 26, 2015. The target action date for the medication is July 24, 2015.
The biologics license application for Praluent contains data on more than 5000 patients spanning over 10 Phase III trials. PCSK9 interferes with the clearance of low-density lipoprotein cholesterol, a leading known risk factor for heart disease.
Sanofi and Regeneron may beat the other potential first entrants in the PCSK9 space, such as Amgen’s evolocumab, as a result of the use of a purchased priority review voucher. The companies got the Rare Pediatric Disease Priority Review voucher through BioMarin for $67.5 million, which had in turn won it when it received approval of Vimizim (elosulfase alfa) for Morquio A syndrome. "Leveraging the sale of the Priority Review Voucher to reinvest in products to treat rare and ultra-rare diseases makes the most sense for BioMarin given our stage of growth," said Jean-Jacques Bienaimé, CEO of BioMarin, at the time of the sale.
Alnylam and Pfizer are also developing anti-PCSK9 treatments. Pfizer’s candidate, which is in Phase II trials, has a proposed generic name of bococizumab.