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FDA grants alirocumab CV outcomes indication
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Sanofi and Regeneron announced that alirocumab has been approved to reduce the risk for MI, unstable angina requiring hospitalization and stroke in patients with established CVD.
The PCSK9 inhibitor (Praluent, Sanofi/Regeneron) has also been approved for use as a monotherapy, in conjunction to diet or combined with other lipid-lowering therapies such as ezetimibe or statins for patients with primary hyperlipidemia, according to a press release from the companies.
“In clinical practice, what this [approval] should mean is that we need to have a greater urgency to use alirocumab in appropriate patients to reduce the risk of MI, stroke and unstable angina,” Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, chief medical officer of Excel Medical Clinical Trials, clinical affiliate professor of biomedical science at Florida Atlantic University in Boca Raton, immediate past president of the American Society of Preventive Cardiology and Cardiology Today Editorial Board Member, said in an interview.
Alirocumab was originally approved in 2015 to lower LDL in addition to diet and maximally tolerated statin therapy in patients with heterozygous familial hypercholesterolemia or those with clinical atherosclerotic CVD. It is also the only PCSK9 inhibitor available in 75 mg and 150 mg doses, allowing health care providers to alter treatment based on their patients’ needs, according to the release.
This approval was based on results from the ODYSSEY Outcomes trial. As Cardiology Today previously reported, reducing LDL to very low levels with alirocumab lowered risk for major adverse CV events and all-cause mortality in patients with ACS on statin therapy.
“Clinical trials provide the evidence for the use of novel treatments, and ODYSSEY Outcomes justifies the use of the PCSK9 inhibitor alirocumab in these high-risk patients,” Robert Rosenson, MD, FACC, FACP, FAHA, FESC, professor of medicine (cardiology) at Mount Sinai School of Medicine and director of cardiometabolic disorders at Mount Sinai Medical Center, told Cardiology Today. “Favorable clinical trial outcomes in well-conducted studies serve as a critical benchmark for guidelines and insurance approval of these treatments for the high-risk cardiovascular disease patients.”
This approval confirms the effectiveness of alirocumab, experts said.
“The approval of alirocumab for cardiovascular morbidity by the FDA is another validation that PCSK9 inhibitors are an important clinical tool to lower LDL to further address residual atherogenic lipid risk,” Michael H. Davidson, MD, FACC, FACP, FNLA, clinical professor of medicine and director of preventive cardiology at University of Chicago Medicine and Cardiology Today Editorial Board Member, said in an interview. “Hopefully we may be able to use alirocumab more broadly in our dyslipidemic patients with less hassle from the payers. My hope is that as these therapies become more available for patients, we can again focus on getting back to ‘lower is better’ for our patients.” – by Darlene Dobkowski
For more information:
Robert Rosenson, MD, FACC, FACP, FAHA, FESC, can be reached at Mount Sinai Comprehensive Health Program Downtown, 275 Seventh Ave., 12th Floor, New York, NY 10001; email: robert.rosenson@mssm.edu.
Seth J. Baum, MD, FACC, FACPM, FAHA, FNLA, FASPC, can be reached at 7900 Glades Road, #400, Boca Raton, FL 33434; email: sjbaum@fpim.org; Twitter: @sethjbaummd.
Michael H. Davidson, MD, FACC, FACP, FNLA, can be reached at 150 E. Huron St., Suite 900, Chicago, IL 60611; email: mdavidso@bsd.uchicago.edu; Twitter: @mdavidsonmd.
Disclosures: Baum reports he consulted, spoke and has conducted clinical trials for Amgen, Regeneron and Sanofi. Rosenson reports his institution receives support from Regeneron for a clinical trial using alirocumab and the angiopoietin-like 3 protein inhibitor evinacumab. Davidson reports he is a speaker and consultant for Amgen, Regeneron and Sanofi.