Sanofi and Regeneron Pharmaceuticals Inc.'s Praluent met the primary endpoints in two phase 3b/4 studies of patients with diabetes and hypercholesterolemia.
Praluent reduced low-density lipoprotein cholesterol, or LDL-C, by 48.2% from baseline when administered on top of maximally tolerated doses of statins and was superior to usual care in reducing non-high-density lipoprotein cholesterol, or non-HDL-C, in the trials.
Approximately 80% patients reached their LDL-C goals with Praluent 75-milligrams every two weeks under the trial, which is also the recommended starting dose for the drug.
In a previously reported study, Praluent 150 milligrams on top of maximally tolerated doses statins reduced LDL-C by 60% from baseline in diabetic patients at week 24.
The drug was well-tolerated in the patient populations and the most common adverse effects were common cold symptoms, urinary tract infections and diarrhea, among others.
Praluent inhibits the binding of proprotein convertase subtilisin/kexin type 9, or PCSK9, to the LDL receptor, which increases the number of available LDL receptors on the surface of liver cells, resulting in lower LDL-C levels in the blood.
The positive results from the Odyssey trials "provide valuable information on the efficacy and safety of Praluent" on diabetic patients who are at high risk of cardiovascular diseases, said Lawrence Leiter, chair of the Odyssey Steering Committee and director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael's Hospital, University of Toronto, Canada.