FDA Approves Ponesimod for Relapsing Multiple Sclerosis

The Food and Drug Administration (FDA) has approved ponesimod (Ponvory; Janssen, Titusville, NJ) for the treatment of relapsing forms of multiple sclerosis (MS). Ponesimode is an oral medication, taken once daily. In a randomized double-blind head-to-head phase 3 clinical trial (NCT02425644), 71% of participants treated with ponesimod had no confirmed relapses vs 61% of those treated with teriflunomide (Aubagio; Sanofi Genzyme, Bridgewater, NJ). 

Ponesimod treatment also reduced occurrence of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively compared with teriflunomide. Both ponesimod and teriflunomide prevented 3-month disability worsening for 90% of participants.

"In the pivotal study, ponesimod demonstrated superior clinical efficacy in reducing annual relapses and MRI activity compared with teriflunomide, another oral MS therapy. Those results, combined with a favorable side effect profile, make ponesimod a useful treatment option for people with relapsing MS," said Robert J. Fox, MD, staff neurologist, Mellen Center for MS Treatment and Research, vice-chair for research, Neurological Institute, Cleveland Clinic. Dr. Fox has served as a paid consultant to Actelion Pharmaceuticals Ltd and Janssen as a member of the ponesimod Advisory Board.

The safety profile of ponesimod was similar to both placebo and teriflunomide in clinical trials, with the most common adverse events in the phase 3 trial being upper respiratory infection, hepatic transaminase elevation and hypertension.