FDA Approves Adjunctive Praluent to Reduce Risk for Stroke, Myocardial Infarction

George Yancopoulos, MD, PhD

The FDA has approved alirocumab (Praluent, Regeneron, Sanofi) to reduce the risk for stroke, myocardial infarction, and unstable angina in people with established cardiovascular disease.¹

Praluent has also been approved to reduce low-density lipoprotein in patients with primary hyperlipidemia as an adjunt to diet, alone, or in combination with other lipid-lowering agents.

Based on data from the ODYSSEY OUTCOMES trial², alirocumab is the first proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor to show a meaningful reduction in all-cause mortality.

“The Phase 3 ODYSSEY OUTCOMES trial showed that people who received Praluent significantly reduced their risk for serious cardiovascular events. There was also a clinically-meaningful reduction in death from any cause with Praluent treatment,” Regeneron president and CEO George D. Yancopoulos, MD, PhD, said in a statement.¹ “With this approval, and the recent introduction of a lower US Praluent list price, we hope that more patients in need will be able to access Praluent.”

The multicenter, randomized, double-blind, placebo-controlled ODYSSEY OUTCOMES trial (NCT01663402) included 18,924 patients with a previous acute coronary syndrome in the past 12 months with a low-density lipoprotein level of ³70 mg per deciliter, and who were receiving high-intensity statin therapy. The primary endpoint was a composite of time to first nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, death from coronary heart disease, or unstable angina requiring hospitalization.

Compared with patients receiving statins alone, those who received adjunctive alirocumab experienced an overall 15% reduction in risk for major cardiovascular events (hazard ratio 0.85; 95% CI: 0.78-0.93, P =.0003), including a 27% reduction in stroke risk, 14% reduction in risk for nonfatal myocardial infarction, 39% reduction in risk for unstable angina, and a 15% reduced risk for all-cause mortality.

Adverse events were similar between both groups, including non-cardiac chest pain, nasopharyngitis, and myalgia. Notably, 3.8% of patients in the treatment group experienced injection-site reactions vs 2.1% of the placebo group.

Praluent is available in 2 doses in order to accommodate a more personalized treatment plan: a single 1 mL injection (75 mg/150 mg) given once every 2 weeks, or a 300 mg dose given once monthly.

REFERENCES

1. FDA approves Praluent ^® (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalization [news release]. Tarrytown, NY: Regeneron Pharmaceuticals. April 26, 2019. Accessed April 29, 2019. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-praluentr-alirocumab-prevent-heart-attack-stroke

2. Schwartz GG, Steg PG, Szarek M, et al. Alirocumab and cardiovascular outcomes after acute coronary syndrome. N Engl J Med. 2018;379(22):2097-2107.