FDA Approves Once-Monthly Dosing for Praluent Injection

The FDA has approved Sanofi and Regeneron’s new supplemental biologics license application for a once-monthly, 300-mg dose of Praluent (alirocumab) injection.

Praluent is indicated for the treatment of adults with high low-density lipoprotein (LDL) cholesterol, as well as an adjunct to diet and maximally tolerated statin therapy in adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL cholesterol.

The new dosing schedule was approved based on results from a phase 3 trial, which evaluated the safety and efficacy of Praluent 300 mg every 4 weeks compared to placebo in patients with hypercholesterolemia who were also taking a concomitant statin. The recommended dose in the United States is 75 mg once every 2 weeks administered subcutaneously, or 300 mg once every 4 weeks for patients who prefer less frequent dosing. Doses can be adjusted to a maximum doe of 150 mg every 2 weeks for patients requiring greater LDL cholesterol reductions.

Praluent 300 mg is administered via 2,150-mg injections at 2 different injection sites.

Local injection site reactions were reported more in patients receiving an injection of Praluent every 4 weeks as compared to those receiving a 75-mg dose every 2 weeks or a placebo.

Reference

Sanofi and Regeneron announce FDA approval of a new once-monthly dosing option for Praluent (alirocumab) injection [news release]. Sanofi’s website. http://www.news.sanofi.us/2017-04-25-Sanofi-and-Regeneron-Announce-FDA-Approval-of-a-New-Once-Monthly-Dosing-Option-for-Praluent-R-alirocumab-Injection. Accessed April 25, 2017.