Posted by Michael Wonder on 05 Mar 2020
Janssen submits European marketing authorisation application for ponesimod for treatment of adults with relapsing multiple sclerosis
4 March 2020 - Janssen announced today the submission of a marketing authorisation application to the European Medicines Agency seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis.
The application is based on the head-to-head OPTIMUM Phase 3 study, which showed superior efficacy of ponesimod 20 mg on the primary endpoint of reduced annualized relapse rate, as well as most secondary endpoints compared to teriflunomide 14 mg in adults with relapsing MS.
