FDA Expands PCSK9 Inhibitor Indication

The FDA has expanded the indication of Praluent (alirocumab) to include the reduction of risk for myocardial infarction, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.

The expansion is based upon results from the ODYSSEY OUTCOMES trial, which assessed the effects of adding Praluent to maximally-tolerated statins on cardiovascular outcomes in 18,924 patients with acute coronary syndrome.

Overall, those patients who received the proprotein convertase subtilisin/kexin type 9 (PCSK9) had a 15% reduced risk for major cardiovascular events, a 27% reduced risk of stroke, 14% reduced risk of non-fatal heart attack, 39% reduced risk of unstable angina requiring hospitalization, and a 15% reduced risk of death from any cause.

The most common adverse events were non-cardiac chest pain, nasopharyngitis, and myalgia.

—Michael Potts

Reference:

FDA approves Praluent® (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalization [press release]. Tarrytown, New York. April 26, 2019.  https://investor.regeneron.com/news-releases/news-release-details/fda-approves-praluentr-alirocumab-prevent-heart-attack-stroke