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 3 OPTIMUM trial, a multicentre, randomised, double-blind, parallel-group, active-controlled superiority study of 1,133 adult patients 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 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualized 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.
“At Janssen, our mission is to reduce the burden, disability and devastation caused by diverse diseases of the central nervous system, including multiple sclerosis, for which there remains significant unmet patient need,” said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. “The approval of ponesimod by the European Commission is a significant milestone as it showcases our continued commitment in neurology, reflecting our deepened focus and commitment to this space.”
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