Sanofi’s Praluent got much needed boost with USFDA new indication approval

The Food and Drug Administration (FDA) has approved Praluent (alirocumab; Sanofi and Regeneron), a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, to reduce the risk of myocardial infarction (MI), stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

The approval was based on data from the ODYSSEY OUTCOMES trial, a double-blind, placebo-controlled study conducted in 18,924 patients who had experienced an acute coronary syndrome (ACS) in the previous 12 months. The primary outcome measure of the study was a composite of death from coronary heart disease, nonfatal MI, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization.

In addition, the FDA has approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce low-density lipoprotein cholesterol (LDL-C).

Praluent is approved in more than 60 countries worldwide, including the US, European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil. In the US, Praluent is approved to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization. Praluent is also approved as an adjunct to diet, alone or in combination with other lipid lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.