FDA to review sBLA for Praluent

The US Food and Drug Administration has accepted a supplemental Biologics License Application (sBLA) for Praluent (alirocumab) Injection, a PCSK9 inhibitor.

Filed by US biotech Regeneron Pharmaceutical (Nasdaq: REGN) and French partner Sanofi (Euronext: SAN), the sBLA outlines a proposed update to the Prescribing Information to include the effect of Praluent in reducing the overall risk of major adverse cardiovascular events (MACE). MACE is an umbrella term that includes heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. The FDA set a Prescription Drug User Fee Act (PDUFA) action date of April 28, 2019.

In its current indications, Praluent generated second quarter 2018 sales of 62 million euros ($72 million) for Sanofi, whose shares edged up 0.94% to 73.96 euros in morning trading today.