Janssen’s MS treatment Ponvory is granted UK marketing authorisation
pharmafile | August 11, 2021 | News story | Research and Development |
The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorisation in Great Britain for PONVORY (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS).
The MHRA authorisation 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) with RMS in 28 countries.
The trial was designed to evaluate the efficacy and safety of once-daily oral ponesimod (20 mg) vs. once-daily teriflunomide (14 mg), an approved and established first-line oral treatment, in adult patients with RMS.
The study showed superior efficacy of ponesimod (n=567) on the primary endpoint, ARR, with a relative rate reduction of 30.5 percent (p=0.0003) compared with teriflunomide (n=566).
Tito Roccia, Therapeutic Area Medical Affairs Director, Neuroscience and Immunology, Janssen-Cilag Ltd, said: “We are delighted to receive MHRA authorisation for ponesimod, Janssen’s first treatment for relapsing multiple sclerosis.
“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.”
Gavin Giovannoni, Professor of Neurology, Blizzard Institute, Barts and The London School of Medicine and Dentistry, said: “Unfortunately, there is no cure for multiple sclerosis and a high unmet medical need remains.
“Most people are diagnosed with multiple sclerosis in their younger years, between the ages of twenty to forty. As such, people living with multiple sclerosis are often looking for treatment solutions which help to minimise the burden and impact the condition has on their daily lives.
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.”
Lilly Subbotin
