Posted by Michael Wonder on 25 Apr 2017
Sanofi and Regeneron announce FDA approval of a new once monthly dosing option for Praluent (alirocumab) injection
25 April 2017 - Monthly dosing schedule now approved in both United States and European Union.
Sanofi and Regeneron Pharmaceuticals today announced that the U.S. FDA approved the companies' new supplemental biologics license application for a once monthly (every four weeks), 300 mg dose of Praluent (alirocumab) Injection for the treatment of adults with high low-density lipoprotein (LDL) cholesterol.
Praluent is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolaemia or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of LDL cholesterol. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.
