Sanofi and Regeneron has gotten the approval from the U.S. Food and Drug Administration (FDA) for Biologics License Application (sBLA) for Praluent Injection, a PCSK9 inhibitor.
The company said in an announcement on Wednesday that 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.
According to Sanofi’s announcement, the sBLA is supported by data from ODYSSEY OUTCOMES, a Phase 3 cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an acute coronary syndrome (ACS), such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial.
The effect of Praluent on cardiovascular morbidity and mortality, including MACE, is currently being reviewed and has not been fully evaluated by any regulatory authority, Sanofi said.