Sanofi and Regeneron Pharmaceuticals announced on March 23 top-line results from a phase 3 study evaluating alirocumab (Praluent) in patients with heterozygous familial hypercholesterolemia whose cholesterol levels required chronic, weekly or bi-weekly apheresis therapy.
The companies said in a news release that the ODYSSEY ESCAPE trial met its primary endpoint. The full results will be presented at upcoming medical conferences, although the companies did not identify which ones.
Patients who received alirocumab along with their existing treatment had a 75 percent reduction in the frequency of their apheresis therapy compared with a placebo group. In addition, 63 percent of patients in the alirocumab group no longer required apheresis, a procedure in which low-density lipoprotein cholesterol is removed from the blood. All of the patients in the placebo group still required apheresis, according to the companies.
Sanofi and Regeneron Pharmaceuticals said apheresis could cost up to $100,000 for each patient per year in the U.S. There are only approximately 60 apheresis centers in the U.S.
In July 2015, the FDA approved alirocumab, an injectable cholesterol-lowering medication and the first commercially available proprotein convertase subtilisin kexin type 9 inhibitor. In March, a Delaware judge ruled against Sanofi and Regeneron Pharmaceuticals in a patent case. The companies said they would continue selling alirocumab despite the legislation.