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The Janssen Pharmaceutical Companies of Johnson & Johnson revealed that EMA's CHMP has issued a positive opinion for Ponvory (ponesimod) for the treatment of RMS.
In a March 26, 2021 press release, the Janssen Pharmaceutical Companies of Johnson & Johnson revealed that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for Ponvory (ponesimod).
CHMP’s positive opinionrecommends marketing authorization for ponesimod for the treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease or imaging features. Phase III trial data that evaluated the efficacy and safety of ponesimod versus teriflunomide were used as the basis for CHMP’s decision.
“Relapsing forms of multiple sclerosis (MS) have varied and often unpredictable symptoms, posing a unique human, societal, and economic burden,” said Catherine Taylor, vice-president, Medical Affairs Therapeutic Area Strategy, Europe, Middle East, and Africa (EMEA), Johnson & Johnson Middle East FZ-LLC, in the press release. “Despite continuous innovations in the treatment landscape, unmet needs remain. If approved by the European Commission, ponesimod has the potential to help more people living with relapsing forms of MS.”
“This is a significant milestone and an important step forward in our goal to make a positive impact for patients with significant unmet needs and unique societal challenges,” added Bill Martin, Global Therapeutic Area head, Neuroscience, Janssen Research & Development, LLC, in the press release. “The positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research which ultimately showed the treatment offers RMS patients superior efficacy on the primary endpoint of reduced annualized relapse rate compared to an established therapy, as well as a proven safety profile.”
Janssen’s marketing authorization application, which was submitted to EMA in March 2020, will now be reviewed by the European Commission.