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CHMP recommends Ponvory for the treatment of adult patients with relapsing multiple sclerosis. Janssen Pharma

Read time: 1 mins
Published:27th Mar 2021
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorisation for Ponvory (ponesimod) for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features The European marketing authorisation application (MAA) 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) in 28 countries.The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod (20mg) vs. once daily teriflunomide (14mg), an approved and widely-used first-line oral standard of care, in adult patients with RMS. The Phase III study showed superior efficacy of ponesimod 20mg on the primary endpoint, annualised relapse rate (ARR), with a rate reduction of 30.5% (p=0.0003) compared with teriflunomide. Ponesimod also showed statistically significant superiority on combined unique active lesions (CUAL), one of the secondary endpoints. Ponesimod significantly reduced the number of new inflammatory lesions on brain MRI by 56% (p<0.0001) at week 108 when compared to teriflunomide.>
Condition: Multiple Sclerosis
Type: drug

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