The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Ponvory (ponesimod) for the treatment relapsing multiple sclerosis (RMS).
The British medicines regulator has cleared Ponvory for the treatment of adult RMS patients with active disease, as defined by clinical or imaging features.
The authorisation is based on data from the Phase III OPTIMUM trial of 1,133 adult patients with RMS in 28 countries. The trial evaluated the efficacy and safety of once-daily oral Ponvory compared with once-daily Sanofi’s Aubagio (teriflunomide), which is an approved and established first-line oral treatment for RMS.
The Phase III study showed superior efficacy of Janssen’s drug compared with Aubagio on the primary endpoint of annualised relapse rate (ARR). Ponvory also showed superiority on one of the secondary endpoints, combined unique active lesions (CUALs), with relative reduction of new or enlarging inflammatory lesions on brain MRI by 56%.
Tito Roccia, therapeutic area medical affairs director, neuroscience and immunology, Janssen-Cilag, said: “We are committed to helping people living with MS and this milestone is a positive step forward in providing a new therapeutic solution which can help to address some of the life-long and life-limiting symptoms of MS.”
“Unfortunately, there is no cure for multiple sclerosis and a high unmet medical need remains,” commented Gavin Giovannoni, professor of neurology, Blizzard Institute, Barts and The London School of Medicine and Dentistry.
“Disease modifying treatments for relapsing multiple sclerosis are designed to reduce the number and severity of relapses, as well as slow disease and disability progression. Having a new oral therapy will provide patients with greater choice," he added.