Benzinga | Mar 19, 2021 09:31AM EDT

Janssen's Ponvory Wins FDA Nod For Relapsing Multiple Sclerosis

The FDA has approved Janssen's a unit of Johnson & Johnson (NYSE: JNJ) Ponvory (ponesimod) for relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

* Ponvory is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator.

* The FDA approval is based, in part, on a two-year head-to-head Phase 3 trial in which Ponvory 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to Sanofi SA's (NASDAQ: SNY) Aubagio 14 mg (teriflunomide) in patients with relapsing MS.

* Over the study period, 71% of patients treated with Ponvory had no confirmed relapses, compared to 61% in the teriflunomide group.

* Price Action: JNJ shares are trading 0.3% higher at $160.91 on the last check Friday.