European Commission approves Ponvory a once daily, oral therapy for the treatment of relapsing forms of multiple sclerosis – Janssen

Janssen, the Pharmaceutical Companies of Johnson & Johnson, announced that the European Commission (EC) has approved Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

The EC approval of ponesimod is based on data from the Phase III OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients (aged 18-55 years) in 28 countries. The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod (20mg) vs. once-daily teriflunomide (14mg), an approved and widely-used first-line oral treatment, in adult patients with RMS. The large, Phase III study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5 percent (p<0.001) compared with teriflunomide. Ponesimod also showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions (CUALs). Ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56 percent (p<0.0001) at week 108 when compared to teriflunomide.