Regeneron Pharms and Sanofi (SNY) present results from ongoing 52 week ODYSSEY JAPAN trial showing LDL-C reductions in more than 60% of patients
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the Phase 3 ODYSSEY JAPAN trial of the investigational therapy Praluent Injection met its primary endpoint.
- At week 24, patients in the Praluent group experienced an average 64% greater reduction from baseline in their bad cholesterol, known as low-density lipoprotein cholesterol (LDL-C), when added to current standard of care including statins, compared to standard of care alone
- Patients were started on the lower dose of 75 mg, with the option to adjust their dose to 150 mg if they had not achieved their LDL-C goal (as defined by the Japan Atherosclerosis Society guidelines) at week 8. At week 24, 97% of patients in the Praluent group reached their LDL-C treatment goal, compared to 10% for placebo
- Ninety-nine% of patients treated with Praluent remained on the lower dose; two patients required adjustment to the higher dose.