MHRA approval for Janssen’s Ponvory for relapsing multiple sclerosis

Novartis' Rydapt (mydostaurin) approved

The Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorisation in Great Britain for 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 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.

Ponesimod is an oral, highly selective S1P1 modulator that functionally inhibits S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.

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.”