The U.S. Food and Drug Administration (FDA) approved a once-monthly, 300 mg dose of alirocumab (Praluent), an injectable proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor used to treat adults with high low-density lipoprotein (LDL) cholesterol.
Regeneron Pharmaceuticals and Sanofi announced the approval on April 25.
In July 2015, the FDA approved alirocumab in 75 mg and 150 mg doses administered subcutaneously every two weeks. It was the first PCSK9 inhibitor commercially available in the U.S.
The medication is intended for patients with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional LDL cholesterol lowering.
With the 300 mg dose, patients will receive two, 150 mg injections at two sites every four weeks, according to the companies. The European Commission had approved the 300 mg dose in November 2016.
The FDA approved the once-monthly dose based on results of the ODYSSEY CHOICE I study, which enrolled patients with hypercholesterolemia who were taking statins. During the study, local injection site reactions were more common in patients receiving alirocumab every four weeks compared with patients with receiving 75 mg of the medication or placebo every two weeks.
In January, a federal judge ruled that Sanofi and Regeneron could not market or sell alirocumab in the U.S. However, an appeals court granted a temporary stay of that ruling in February, allowing the companies to continue to market, sell and distribute alirocumab during the appeals process.
The companies generated $116.3 million in alirocumab sales in 2016, including $94.4 million in the U.S. and $21.9 million outside the U.S.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.