Breakthrough PCSK9 Inhibitor Gets FDA Panel Approval
An FDA advisory committee voted 13-3 in favor of recommending alirocumab (Praluent, Sanofi and Regeneron Pharmaceuticals, Inc.), an injectable proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor, for the long-term treatment of patients with hypercholesterolemia and dyslipidemia.
PCSK9 inhibitors, which work by blocking PCSK9 enzymes in the liver and, thereby, lowering the amount of low-density lipoprotein (LDL) cholesterol in the blood, represent a promising alternative for statin-intolerant patients with hypercholesterolemia.
Can PCSK9 Inhibitors Improve Hypercholesterolemia Outcomes
FDA Roundup: New Indication for Hep C Regimen
The committee’s vote for approval was based on data from 10 multicenter phase III trials involving more than 5000 patients. Overall, researchers found that treatment with alirocumab was associated with an absolute LDL reduction of 36% to 61% from baseline, and a treatment difference of 39% to 62% compared with placebo.
The drugs safety was examined in 4 phase II trials, in which the most common adverse events reported were injection site reaction and pruritus.
The FDA is not bound by the decision of the advisory committee, but will take their vote into consideration. They will make their final decision on whether or not to approve alirocumab by July 24, 2015.
The advisory committee will review a similar PCSK9 inhibitor, evolocumab, on June 10, 2015.
Sanofi. FDA advisory committee recommends approval of Sanofi and Regeneron's Praluent® (alirocumab) injection for patients with hypercholesterolemia [press release]. June 9, 2015. http://www.news.sanofi.us/2015-06-09-FDA-Advisory-Committee-Recommends-Approval-of-Sanofi-and-Regenerons-Praluent-alirocumab-Injection-for-Patients-with-Hypercholesterolemia. Accessed June 10, 2015.