French pharma major Sanofi (Euronext: SAN) and US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) have received Japanese approval for Praluent (alirocumab) to treat uncontrolled low-density lipoprotein (LDL) cholesterol, in certain patients with hypercholesterolemia at high cardiovascular risk.
Praluent is a human monoclonal antibody targeting proprotein convertase subtilisin/kexin type 9, or PCSK9, and in Japan it is indicated for the treatment of patients with hypercholesterolemia and familial hypercholesterolemia who are at high cardiovascular risk, and in whom treatment with statins is not sufficient.
Doses of 75mg and 150mg will be available in Japan as a single-dose pre-filled pen and syringe.
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