FDA Approves Ponesimod for Adults With Relapsing Multiple Sclerosis

On March 19, 2021, the US Food and Drug Administration approved ponesimod (Jansenn, Ponvory) for the treatment of adults with relapsed multiple sclerosis.

The FDA approval is based on data from a two year, head-to-head phase 3 OPTIMUM clinical trial. In this study, 1,133 patients with relapsing multiple sclerosis were enrolled to receive ponesimod or teriflunomide.

The primary efficacy endpoint was the annual relapse rate from baseline through the study period. Additional efficacy endpoints included the number of new gadolinium-enhancing T1 lesions from baseline to week 108, the number of new or enlarging T2 lesions from baseline to week 108, and the time to 3-month and 6-month confirmed disability progression.

A total of 71% of patients treated with ponesimod had no confirmed relapses over the study period compared to 61% of patients in the teriflunomide arm. Ponesimod demonstrated superior efficacy in the trial, reducing annual relapses by 30.5% compared to teriflunomide.

Ponesimod also demonstrated superiority in reducing the number of gadolinium-enhancing T1 lesions and the number of new or enlarging T2 lesions compared to teriflunomide.

The most common adverse events observed in the ponesimod arm of the phase 3 trial were upper respiratory infection, hepatic transaminase elevation and hypertension.

The FDA approval follows more than 10 years of data demonstrating the treatment’s efficacy and safety.—Kaitlyn Manasterski


Reference: Janssen Announces U.S. FDA Approval of PONVORY™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions. News Release.Updated March 19, 2021.http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20210319:nPn2CWjrGa&default-theme=true Accessed April 05, 2021.