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. 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. 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).Įxpanded Indication to Include Patients with Other Types of High LDL-C *Because statistical testing of these endpoints was performed outside of the hierarchy, the results are not considered statistically significant.Īdverse events were similar between the Praluent and placebo groups, except for injection site reactions (Praluent 3.8%, placebo 2.1%). Patients who received Praluent in the trial experienced:Ī 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.* 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. Praluent list price, we hope that more patients in need will be able to access Praluent." With this approval, and the recent introduction of a lower U.S. There was also a clinically-meaningful reduction in death from any cause with Praluent treatment. "The Phase 3 ODYSSEY OUTCOMES trial showed that people who received Praluent significantly reduced their risk for serious cardiovascular events. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. "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. Adults who experience a heart attack or stroke have an approximately one in three chance to have another CV event. 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. "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." "Today's FDA approval marks a significant achievement in the treatment of adults with established cardiovascular disease, who are among those at greatest risk of death or disability caused by serious cardiovascular events," said John Reed, M.D., Ph.D., Global Head of Research & Development, Sanofi. Food and Drug Administration (FDA) has approved Praluent ® (alirocumab) to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. Praluent treatment effect was observed in patients already receiving other lipid-lowering therapies, including maximally-tolerated statins
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