FDA Approves Drug to Prevent Serious Cardiovascular Events

Officials with the FDA has approved alirocumab (Praluent, Regeneron and Sanofi) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.

The drug also was approved by the agency as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.

High levels of ‘bad’ cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), increase patients' risk for serious CV events such as heart attack or stroke. Adults who experience a heart attack or stroke have an approximately 1 in t3 chance to have another CV event.

"Heart disease accounts for one quarter of all American deaths each year and many others are at risk for heart attack and stroke due to uncontrolled LDL-C levels," said George D. Yancopoulos, MD, PhD, President and Chief Scientific Officer, Regeneron, in a prepared statement. "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. 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."

John Reed, MD, PhD, Global Head of Research & Development, Sanofi, said the FDA approval for alirocumab marks a “significant achievement” in the treatment of adults with established CV disease, including those at greatest risk of death or disability caused by CV events.

"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," said Reed, in a prepared statement.

According to Regeneron, the FDA’s approval is based on data from ODYSSEY OUTCOMES, which 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.

Patients who received alirocumab in the trial experienced a 15% reduced risk for major CV events. The primary endpoint included time to first heart attack, stroke, death from coronary heart disease (CHD), or unstable angina requiring hospitalization (HR 0.85; 95% CI, 0.78 to 0.93; p=0.0003).

Alirocumab was the first PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor approved by the FDA and is the only PCSK9 inhibitor available in 2 doses with 2 levels of efficacy as a single 1 mL injection (75 mg and 150 mg) once every 2 weeks, according to Regeneron. It can also be administered as 300 mg once every 4weeks (monthly), enabling physicians to tailor treatment based on an individual patient's LDL-C-lowering needs.

Reference

FDA APPROVES PRALUENT® (ALIROCUMAB) TO PREVENT HEART ATTACK, STROKE AND UNSTABLE ANGINA REQUIRING HOSPITALIZATION [news release]. Tarrytown, NY and Paris, France; April 26, 2019: Regeneron. https://investor.regeneron.com/news-releases/news-release-details/fda-approves-praluentr-alirocumab-prevent-heart-attack-stroke. Accessed April 2019.