In phase III/IV studies, Praluent (alirocumab) reaches endpoints for dyslipidaemia- Sanofi and Regeneron Pharma

Sanofi and Regeneron Pharmaceuticals announced positive results from two Phase IIIb/IV ODYSSEY-DM trials in patients with diabetes. 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 III program.

Praluent in combination with MTD statins reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was 49 percent (p<0.0001). Treatment with Praluent also improved the overall lipid profile. Overall, Praluent was generally well tolerated. Treatment emergent adverse events (TEAEs) were similar between the two groups and no emerging safety findings were identified from the study. The most frequent TEAEs included nasopharyngitis, myalgia, arthralgia and cough.

There was no new safety signal with the concomitant use of Praluent and insulin. There was no impact on glycemic control as assessed by fasting plasma glucose (FPG), A1C and glucose lowering treatments remained stable over time in both treatment groups. The results were unveiled as part of the official symposium of the 77th Scientific Sessions of the American Diabetes Association.