FDA Approves New LDL-Lowering Agent Alirocumab (Praluent)

Deborah Brauser

July 24, 2015

BETHESDA, MD – As widely expected, the US Food and Drug Administration (FDA) today approved alirocumab (Praluent, Sanofi/Regeneron) for lowering LDL cholesterol (LDL-C). The indication is for patients with heterozygous familial hypercholesterolemia or those at high CV risk who cannot lower their LDL-C with statins[1].

This is the first proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor to be approved in the US, although the agency is widely expected to approve another PCSK9 inhibitor, evolocumab (Repatha, Amgen), within weeks. As reported by heartwire from Medscape, alirocumab received an approval recommendation from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA in June.

Earlier today, the drug, which is delivered via subcutaneous injection, was also recommended for approval by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. That recommendation is now on its way to the European Commission (EC), which will make the final decision on whether to grant marketing authorization throughout the European Union. The EC approved the drug's PCSK-9 competitor evolocumab earlier this week.

Alirocumab was approved before the completion of its CV-outcomes trial. The primary outcome measures for ODYSSEY-Outcomes, which is scheduled to finish by December 2017, include possible first occurrence of CHD death, any nonfatal MI, fatal and nonfatal ischemic stroke, and unstable angina requiring hospitalization. Secondary measures included time to first occurrence of any CHD event, major CHD event, any CV event, and all-cause mortality.

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