Sanofi and Regeneron gain US FDA approval of Praluent

26 July 2015

There was a second piece of good news on Friday for Regeneron Pharmaceuticals (Nasdaq: REGN) and its partner France’s Sanofi (Euronext: SAN), when the US Food and Drug Administration approved Praluent (alirocumab) Injection.

Praluent becomes the first FDA-approved treatment in a new class of drugs known as PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors. Earlier the same day, it was announced that the European Medicines Agency’s advisory unit had recommended approval of the drug (The Pharma Letter July 24).

Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of low-density lipoprotein (LDL) cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

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