Background Analysis: US FDA Advisory Committee to Review Regeneron Pharmaceuticals’ and Sanofi Aventis’ PCSK9 Inhibitor, PRALUENT (Alirocumab), for High Cholesterol – JUN 9, 2015 (EMDAC)
The US FDA has scheduled an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting for Tuesday, June 9, 2015. The Committee will discuss the safety and efficacy of PRALUENT (Alirocumab) for injection, submitted by Sanofi Aventis, U.S. (Sanofi) for the treatment of high cholesterol (BLA Number 125559). The full proposed indication is for use an adjunct to diet, for long-term treatment of adult patients with primary hypercholesterolemia (non-familial and heterozygous familial) or mixed dyslipidemia including patients with type 2 diabetes mellitus, to reduce low-density lipoprotein cholesterol, total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein B, triglyceride, and lipoprotein A, and to increase high-density lipoprotein cholesterol and apolipoprotein A-1, either in combination with a statin or as monotherapy, including in patients who cannot tolerate statins.
Sanofi is collaborating with Regeneron Pharmaceuticals (Regeneron) to develop this product; however, the FDA announcement lists only Sanofi as the sponsor.