For research and educational purposes only. Not medical advice.
Alirocumab Reference
Educational, not medical advice reference for Alirocumab: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Also known as Pr…
Reference summary
ODYSSEY OUTCOMES (Schwartz 2018 NEJM, n=18,924) randomized patients with acute coronary syndrome in the prior 1 to 12 months to alirocumab vs placebo on top of high-intensity statin. The primary 4-component MACE composite was reduced by 15 percent relative over a median 2.8 years; pre-specified subgroup analysis suggested larger benefit in patients with baseline LDL-C at or above 100 mg/dL.
Regulatory and posture
- Categories
- Metabolic
- Aliases
- Praluent, REGN727, SAR236553, Fully human IgG1 PCSK9-targeting monoclonal antibody
- Evidence posture
- human
- Regulatory status
- FDA-approved as Praluent (2015) as an adjunct to diet and maximally tolerated statin therapy for adults with primary hypercholesterolemia (including HeFH); and to reduce risk of MI, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular disease.
- Content review status
- label verified