Ponesimod filed with EU for relapsing multiple sclerosis.- Janssen

Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a MAA to the European Medicines Agency (EMA) seeking approval for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (MS). The application is based on data from the Phase III OPTIMUM study. In the head-to-head, two-year Phase III comparative study, statistically significant reduction of annualized relapse rate (ARR), the study's primary endpoint, was observed with ponesimod when compared to teriflunomide by 30.5% up to week 108 (ARR = 0.202 for ponesimod 20 mg vs. 0.290 for teriflunomide 14 mg, p=0.0003).Several pre-specified secondary endpoints were also examined as part of the OPTIMUM trial, including fatigue. Based on results from the Fatigue Symptoms and Impacts Questionnaire - Relapsing Multiple Sclerosis (FSIQ-RMS) at week 108, statistically significant effects on fatigue symptoms were observed with ponesimod compared to teriflunomide (mean difference: -3.57, p=0.0019). FSIQ-RMS is a new MS-specific, 20-item patient-reported outcome measure that comprises symptoms and impacts with an increase from baseline indicating worsening in fatigue symptoms. The safety profile observed for ponesimod in the OPTIMUM study was consistent with previous studies of ponesimod and the known safety profile for other S1P receptor modulators. The most commonly observed adverse events included nasopharyngitis, headache, upper respiratory tract infections and an increase in alanine amino transferase.