Janssen receives MHRA authorization for Ponvory in RMS

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted Marketing Authorization in Great Britain for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features.

Marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) Janssen unit, Ponvory gained US regulatory approval in March this year and in Europe in May. Analysts have forecast peak potential sales of $200 to $400 million for ponesimod.

The MHRA authorization of ponesimod is based on data from the Phase III OPTIMUM trial, a multicenter, randomized, 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 (20mg) versus once-daily teriflunomide (14mg), an approved and established first-line oral treatment, in adult patients with RMS markted by Sanof (Euronext: SAN) as Aubagio