Sanofi’s and Regeneron’s diabetes drug testing shows positive results

Sanofi and Regeneron Pharmaceuticals have reported positive results from two Phase 3b/4 ODYSSEY-DM trials in patients with diabetes.

Sanofi said in its press release that in the studies, Praluent (alirocumab), when administered on top of maximally tolerated doses (MTD) of statins, significantly reduced low-density lipoprotein cholesterol (LDL-C), the primary endpoint of the ODYSSEY DM-INSULIN study, and was superior to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C), the primary endpoint of the ODYSSEY DM-DYSLIPIDEMIA study. Both studies also found that a majority of patients reached their lipid goals with Praluent 75 mg every two weeks, with an overall safety profile comparable to the ODYSSEY Phase 3 program.

“Patients with long-standing diabetes, including insulin-treated patients, are at high risk of cardiovascular disease,” said Lawrence Leiter, M.D., chair of the ODYSSEY DM Steering Committee and director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael’s Hospital, University of Toronto, Canada. “The positive results from ODYSSEY DM-INSULIN provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group.”

“Mixed dyslipidemia is common in people with type 2 diabetes and further increases CV risk, and yet it is difficult to treat with available therapies,” said Robert Henry, M.D., member of the ODYSSEY DM Steering Committee and Director of the Center for Metabolic Research at the VA San Diego Healthcare System. “The results of ODYSSEY DM-DYSLIPIDEMIA showed that in a real-world setting, Praluent, on top of maximally tolerated doses of statins, significantly reduced non-HDL-C, another measure of bad cholesterol, and was superior to usual care. Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles.”