Posted by Michael Wonder on 19 Mar 2020
Janssen submits ponesimod new drug application to the U.S. FDA for treatment of adults with relapsing multiple sclerosis
19 March 2020 - Janssen today announced the submission of a new drug application to the U.S. FDA 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 Aubagio (teriflunomide) 14 mg in adults with relapsing multiple sclerosis.
