FDA Approves New MS Treatment Option

The FDA has approved Ponvory (ponesimod) for the treatment of adults with relapsing multiple sclerosis (MS).

The once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator was shown to significantly reduce annual relapse by 30.5% when compared with teriflunomide in a 2-year head-to-head Phase 3 clinical trial. Further, 9 in 10 patients treated with the drug did not worsening of 3-month disability.

Notably, when treatment is stopped, Ponvory’s effects on the immune system are no longer present after 1 to 2 weeks and the drug is no longer present in patients’ blood within 1 week.

The drug has been shown to be well-tolerated over multiple clinical studies. The most common adverse effects included upper respiratory infection, hepatic transaminase elevation and hypertension.

—Michael Potts

Reference:

Janssen announces US 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. Titusville, NJ. March 19, 2021. http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20210319:nPn2CWjrGa&default-theme=true