FDA Approves New Dosing Option for Praluent

The FDA has approved a new once-monthly 300 mg dosing option for Praluent (alirocumab) injection, for the treatment of patients with high low-density lipoprotein (LDL) cholesterol.

The drug is indicated as an adjunct to diet and statin therapy for patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional LDL lowering.
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The new dose was approved based upon the results of a Phase 3 trial (ODYSSEY CHOICE I), which evaluated the efficacy and safety of Prauluent 300 mg every 4 weeks compared with placebo.

The most common side effects of Praluent include injection site reactions, symptoms of the common cold, and flu-like symptoms.

—Michael Potts

Reference:

Regeneron and Sanofi announce FDA approval of a new once monthly dosing option for praluent® (alirocumab) injection [press release]. April 25, 2017. http://files.shareholder.com/downloads/REGN/4225131815x0x938939/F0F44089-0708-4D05-B458-33F84E1125F8/REGN_News_2017_4_25_General_Releases.pdf.