
FDA Accepts Supplemental BLA for Praluent
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
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.
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