Sanofi and Regeneron's Praluent meets primary endpoint in Japan trial

French drug major Sanofi (Euronext: SAN) and US biotech firm Regeneron Pharmaceuticals (Nasdaq: REGN) have announced that the Phase III trial of Praluent (alirocumab) injection met its primary endpoint.

In the ODYSSEY JAPAN trial, 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 75mg, with the option to adjust their dose to 150mg 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. Some 99% of patients treated with Praluent remained on the lower dose; two patients required adjustment to the higher dose.

Reached target levels