Physicians' Academy for Cardiovascular Education

FDA expands indication for PCSK9 inhibitor to prevent major CV events in adults with CVD

News - May 6, 2019

The U.S. Food and Drug Administration (FDA) has approved alirocumab to reduce the risk of MI, stroke, and unstable angina requiring hospitalization in adults with established CVD. The FDA approval is based on data from ODYSSEY OUTCOMES, which were published in the New England Journal of Medicine in November 2018. These data showed a 15% risk reduction of major CV events with alirocumab vs. placebo.

The trial assessed the effect of adding alirocumab to maximally-tolerated statins on CV outcomes in 18,924 patients who had an acute coronary syndrome (ACS) within a year of enrolling in the trial.

Adverse events were similar between the alirocumab and placebo groups, except for injection site reactions (alirocumab 3.8%, placebo 2.1%).

The FDA already approved alirocumab 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.

ODYSSEY OUTCOMES assessed the effect of alirocumab on the occurrence of MACE in patients who had experienced an ACS before enrolling in the trial, and who were already on intensive or maximally-tolerated statin treatment. Patients were randomized to receive alirocumab (n=9,462) or a placebo (n=9,462) and were assessed for a median of 2.8 years, with some patients being treated for up to five years. Approximately 90% of patients were on high-intensity statins prior to randomization.

Source: press release Sanofi, April 26, 2019

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