As Sanofi and Amgen race towards respective PDUFA dates, both are looking to transform the cholesterol drug market with their new advanced PCSK protein-inhibiting drugs.
The two companies have been locked in a patent fight since last October, when Amgen sought an injunction to prevent the infringing manufacture, use and sale of Sanofi/Regeneron alirocumab, a monoclonal antibody targeting PCSK9.
Despite the pending litigation, the FDA accepted Amgen's Biologics License Application (BLA) for Repatha last November, with a standard 10 month review and set a target Prescription Drug User Fee Act date of Aug. 27, 2015.
The FDA accepted the BLA for Sanofi's Praluent (developed with Regeneron Pharmaceuticals) for priority review in January. The FDA is scheduled to announce its decision for the approval of Praluent by July 24, 2015.
Sanofi's Praluent offers a low-dose, lower-cost option, while Amgen's rival Repatha is being touted as a more convenient option for physicians.
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