European regulators have approved Janssen’s Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
The European Commission 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 (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 3 study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5% compared with teriflunomide.
Ponesimod also showed statistically significant superiority on one of the secondary endpoints, combined unique active lesions (CUALs).
The treatment significantly reduced the number of new inflammatory lesions on brain MRI by 56% at week 108 when compared to teriflunomide.
“I welcome the European Commission’s approval of ponesimod as an additional treatment option for those living with relapsing multiple sclerosis – it will provide patients with additional choice when making decisions about their treatment,” said Professor Gavin Giovannoni, Professor of Neurology at Queen Mary University of London.
“The OPTIMUM study is the first Phase 3 study establishing superiority versus another disease modifying treatment for relapsing multiple sclerosis, with ponesimod showing significant reductions in annual relapse rates versus teriflunomide, an active comparator and widely-used first-line oral treatment,” said Catherine Taylor, Vice President, Medical Affairs, Therapeutic Area Strategy, Europe, Middle East and Africa (EMEA), Johnson & Johnson Middle East FZ-LLC.
“The approval of ponesimod by the European Commission is a positive step for people living with relapsing multiple sclerosis, as we work to provide them with an additional treatment option to manage and control their condition.”
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
The EC approval follows the positive CHMP opinion for ponesimod in March 2021 and the announcement of the U.S. Food and Drug Administration (FDA) approval of ponesimod for use in adults with relapsing forms of MS.