Janssen’s Multiple Sclerosis Treatment Scores European Approval

Stuart SchlossmanMS Drug Therapies

 

  • The European Commission has approved Janssen’s, a unit of Johnson & Johnson 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.
  •   Approval follows more than 10 years of cumulative data from Phase 2 and
    Phase 3 studies demonstrating ponesimod’s efficacy and safety1,2,3 
  •  Approval builds on Janssen’s deep-rooted history in neuroscience and
    reinforces Company commitment to addressing unmet needs for
    neurological conditions like MS

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