Sanofi (NYSE:SNY) and Regeneron (NSDQ:REGN) said today that the FDA approved the companies’ new supplemental Biologics License Application for a once-monthly, 300 milligram dose of Praluent as a treatment for adults with high low-density lipoprotein cholesterol.
The 300 milligram dose is administered using 2 pre-filled pens that each deliver 150 milligrams at an injection site. The European Commission approved the once-monthly dose of Praluent (alirocumab) in November last year, Sanofi said.
The drug is indicated as an adjunct to diet and statin therapy for adults with heterozygous familial hypercholesterolemia or clinical artheroslerotic cardiovascular disease.
“The FDA approval of once-monthly Praluent is encouraging news for patients with clinical ASCVD or HeFH because it enables physicians to further tailor their treatment to lower LDL cholesterol,” Dr. Robert Pordy, Regeneron’s VP of cardiovascular & metabolism therapeutics, said in prepared remarks. “Selecting the most appropriate therapy based on individual patient preference is an important consideration for healthcare professionals as high cholesterol treatment often requires long-term management.”
“Many patients in the U.S. continue to struggle with high levels of bad cholesterol, or LDL cholesterol, despite diet, exercise and other lipid-lowering therapies, so new dosing options are welcome additions to the treatment landscape,” Dr. Corinne Hanotin, Sanofi’s global project head of cardiovascular clinical development, added. “Praluent is now the only PCSK9 inhibitor to offer 2 dosage strengths with 2 levels of efficacy, as well as a monthly dosing option.”