The US Food and Drug Administration’s (FDA) endocrinologic and metabolic drugs advisory committee (EMDAC) has recommended Sanofi and Regeneron Pharmaceuticals‘ investigational therapy Praluent (alirocumab) Injection for approval to treat patients with hypercholesterolemia.
The committees recommended the drug through a vote of 13 to three, as the firms sufficiently established low-density lipoprotein cholesterol (LDL-C or bad cholesterol) lowering benefit of Praluent in one or more patient populations.
Sanofi global R&D president Dr Elias Zerhouni said: “Our clinical trial programme focused on patients with high unmet need in which Praluent delivered significant reductions in LDL-C on top of statins and other lipid-lowering therapies.”
Praluent’s recommendation was based on the efficacy and safety data from around 5,000 patients across ten pivotal Phase III double-blind trials ranging from six months to two years.
According to Sanofi, clinical data from the Odyssey Phase III programme demonstrate consistent and positive results in reducing LDL-C.
Regeneron Laboratories chief scientific officer Dr George Yancopoulos said: “The discovery of PCSK9 as a powerful regulator of cholesterol levels and cardiovascular disease was one of the most important human genetic advances of the last decade.”
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The FDA will consider the committee’s recommendation in its review of the biologics licence application (BLA) for Praluent, which was already accepted.
If approved, Praluent is claimed to be the first fully human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9 (PCSK9) in the US.
Image: Yellowish patches consisting of cholesterol deposits above the eyelids are more common in people with familial hypercholesterolemia. Photo: courtesy of Bobtheowl2.