New monthly dose of alirocumab granted approval

The FDA has approved a 300-mg once-monthly dose of alirocumab for injection, Regeneron and Sanofi announced.

The approval of the new dose is based on results from phase 3 ODYSSEY CHOICE I study of alirocumab (Praluent, Sanofi/Regeneron), according to a press release from the companies.

The injection is utilized as treatment in addition to statin therapy and modified diet for patients with heterozygous familial hypercholesterolemia and/or atherosclerotic CVD.

The 300-mg dose is to be administered by two 150-mg injections at two different sites, with each dose to be delivered to the patient in 20 seconds or less using pre-filled pens, according to the release.

“The FDA approval of once-monthly Praulent is encouraging news for patients with clinical [atherosclerotic] CVD or [heterozygous familial hypercholesterolemia] because it enables physicians to further tailor their treatment to lower LDL cholesterol,” Robert Pordy, MD, vice president of cardiovascular and metabolism therapeutics for Regeneron, said in the release. “Selecting the most appropriate therapy based on individual patient preference is an important consideration for health care professionals, as high cholesterol treatment often requires long-term management.”

The recommended dose of alirocumab is 75 mg every two weeks subcutaneously or 300 mg once-monthly, with an increase up to 150 mg every two weeks for those who require further LDL reductions, according to the release.

Alirocumab is not recommended for patients who have had a serious hypersensitivity reaction to the treatment, including allergic reactions and local injection site reactions.

Disclosure: Pordy is an employee of Regeneron.