Janssen's Multiple Sclerosis Treatment Scores European Approval
- The European Commission has approved Janssen's, a unit of Johnson & Johnson (NYSE: JNJ) Ponvory (ponesimod), to treat adult patients with relapsing multiple sclerosis.
- The EC approval of ponesimod is based on data from the Phase 3 OPTIMUM trial that met the primary endpoint of annualized relapse rate (ARR), with a rate reduction of 30.5% compared with teriflunomide.
- Ponesimod also showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions, and reduced the number of new inflammatory lesions on brain MRI by 56% at week 108 compared to teriflunomide.
- The treatment had won FDA approval in March.
- Price Action: JNJ shares are down 0.20% at $170.62 during the market session on the last check Monday.
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Posted-In: Briefs European Medicines Agency (EMA) multiple sclerosisBiotech News Health Care FDA General
