The US Food and Drug Administration (FDA) has given Sanofi’s Praulent (alirocumab) approval to reduce the risk of heart attack, stroke and unstable angina requiring hospitalisation in adults with established cardiovascular (CV) disease.
The approval was based on data from ODYSSEY OUTCOMES, which was published in the New England Journal of Medicine in November 2018 and found Praulent to cause a 15% reduced risk for major CV events, a 27% reduced risk of stroke, 14% reduced risk of non-fatal heart attack and 39% reduced risk of unstable angina requiring hospitalisation as well as a 15% reduced risk of death from any cause.
The 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 John Reed, global head of research & development, Sanofi.
He continued, “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.”
Praluent is the first PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor that has shown a meaningful reduction in death from any cause, and is also available in two doses with two levels of efficacy as a single 1 mL injection (75 mg and 150 mg) once every two weeks. It can also be administered as 300 mg once every four weeks (monthly), enabling physicians to tailor treatment based on an individual patient’s LDL-C-lowering needs.
The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies like statins or orezetimibe for the treatment of adults with primary to reduce LDL-C.