FDA approves new indication for Praluent

The US Food and Drug Administration has approved Praluent(alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

The drug, which gained a similar label extension in Europe last month, was developed by US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) and partner French pharma major Sanofi (Euronext SAN).

"Today's FDA approval marks a significant achievement in the treatment of adults with established cardiovascular disease, who are among those at greatest risk of death or disability caused by serious cardiovascular events," said Dr John Reed, global head of R&D at Sanofi, adding: "Praluent has already helped many adults lower their LDL-C levels, and this new indication provides an opportunity to help appropriate patients by reducing the risk of serious, life-threatening cardiovascular events, including heart attacks and stroke."