FDA Accepts Supplemental BLA for Praluent

September 20, 2018

The agency will review Praluent (alirocumab) Injection, a PCSK9 inhibitor, as a possible treatment of cardiovascular events.

On Sept. 12, 2018, Sanofi announced that FDA had accepted a supplemental biologics license application (sBLA) for Praluent (alirocumab) Injection, a PCSK9 inhibitor. Sanofi and Regeneron Pharmaceuticals, Inc. submitted the sBLA with updated prescribing information to include reducing the overall risk of major adverse cardiovascular events (MACE). Data from ODYSSEY OUTCOMES, a Phase III 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, were used in the sBLA.

A Prescription Drug User Fee Act (PDUFA) action date has been set for April 28, 2019. Sanofi stated in a press release that 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.”

Additional prescribing information was updated and approved by FDA that included the use of the drug in patients with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C (low-density lipoprotein cholesterol) along with diet and maximally-tolerated statin therapy and who are undergoing apheresis treatment. The update is supported by data from the Phase 3 ODYSSEY ESCAPE trial of 62 patients with HeFH, an inherited form of high cholesterol, whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy.

Source: Sanofi