Home » European Commission Authorizes J&J’s Ponvory for Relapsing Multiple Sclerosis
European Commission Authorizes J&J’s Ponvory for Relapsing Multiple Sclerosis
Drugs Submissions and Approvals
The European Commission has approved Johnson & Johnson’s (J&J) Ponvory (ponesimod) for treating adults with relapsing multiple sclerosis (MS), with active disease defined by clinical or imaging features.
The approval was supported by a phase 3 study in 1,133 participants across 28 countries, where Ponvory was shown to reduce relapses by 30.5 percent vs. teriflunomide and reduce new inflammatory lesions on brain MRIs by 56 percent at week 108.
The oral therapy works by reducing the number of lymphocytes, white blood cells in the immune system that can enter the brain and damage myelin, which protects and insulates nerve cells.
The FDA approved Ponvory for the same indication in March.