The European Commission (EC) has cleared Janssen’s Ponvory for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease.
The European approval follows the recent announcement of the US Food and Drug Administration (FDA) approval of Ponvory (ponesimod) for RMS in March 2021.
The EC authorisation is based on data from the Phase III Optimum study, which was designed to evaluate the efficacy and safety of once daily oral Ponvory versus Sanfo’s once-daily MS treatment Aubagio (teriflunomide).
In this study, Ponvory demonstrated superior efficacy, with an annualised relapse rate (ARR) reduction of 30.5% compared with Aubagio.
Janssen’s drug also showed statistically significant superiority on one of the study’s secondary endpoints – combined with unique active lesions (CUALs).
Ponvory was found to significantly reduce the rate of new inflammatory lesion on brain MRI by 56% at week 108 compared with Sanofi’s drug.
The among of treatment-emergent adverse events reported in the Optimum study was also similar between the Ponvory and Aubagio treatment groups, with the majority of side effects being mild to moderate in nature and not causing treatment discontinuation.
“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, global head, Janssen Research & Development, Johnson & Johnson.
“The approval of [Ponvory] 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,” he added.