Sanofi

FDA approves Praluent (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalization - Seite 2

The FDA approval is based on data from ODYSSEY OUTCOMES, which was published in the New England Journal of Medicine in November 2018, assessing the effect of adding Praluent 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 Praluent 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).
• A 27% reduced risk of stroke, 14% reduced risk of non-fatal heart attack and 39% reduced risk of unstable angina requiring hospitalization.*

A 15% reduced risk of death from any cause (also called all-cause mortality; HR 0.85; 95% CI, 0.73 to 0.98; nominal p=0.026) was also observed.*

*Because statistical testing of these endpoints was performed outside of the hierarchy, the results are not considered statistically significant.

Adverse events were similar between the Praluent and placebo groups, except for injection site reactions (Praluent 3.8%, placebo 2.1%). In ODYSSEY OUTCOMES, the adverse events that occurred in >5% of patients included: non-cardiac chest pain (7.0% Praluent, 6.8% placebo), nasopharyngitis (6.0% Praluent, 5.6% placebo) and myalgia (5.6% Praluent, 5.3% placebo).

Expanded Indication to Include Patients with Other Types of High LDL-C
The FDA also approved Praluent 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.

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

About ODYSSEY OUTCOMES
ODYSSEY OUTCOMES, the longest CV outcomes trial of any PCSK9 inhibitor to date, assessed the effect of Praluent on the occurrence of major adverse CV events 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 Praluent (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.