- 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
Click HERE to Subscribe for the MS Beacon eNewsletter
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews