Janssen’s multiple sclerosis treatment recommended by EMA
pharmafile | March 29, 2021 | News story | Sales and Marketing | CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis
Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
The positive opinion was based on the Phase III OPTIMUM study evaluating the efficacy and safety of ponesimod versus teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing MS.
The trial, of 1,133 adults aged between 18 and 55 years old, showed a daily dosage of 20mg of ponesimod had a superior efficacy in reducing annualised relapse rate of multiple sclerosis. It had a rate reduction of 30.5% compared with teriflunomide.
The European Commission will now review the recommendation and, if approved, ponesimod will be the first therapy by Janssen for patients living with MS with active disease defined by clinical or imaging features. The FDA authorised the treatment earlier this month.
In patients with MS, inflammatory immune cells, including lymphocytes, can cross the blood brain barrier into the brain and damage myelin, the protective sheath that insulates nerve cells. Ponesimod works by inhibiting S1P1 receptor activity and, in doing so, it is believed to reduce the number of circulating lymphocytes.
Dr Catherine Taylor, Vice President of Medical Affairs Therapeutic Area Strategy in Europe at Janssen, said: “Relapsing forms of MS have varied and often unpredictable symptoms, posing a unique human, societal and economic burden.
“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.”
Bill Martin PhD, Global Therapeutic Area Head of Neuroscience at Janssen Research & Development, added: “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.
“The positive CHMP opinion for ponesimod is testament to nearly a decade of cumulative clinical research, which ultimately showed the treatment offers relapsing MS patients superior efficacy on the primary endpoint of reduced annualised relapse rate compared to an established therapy, as well as a proven safety profile.”
Jack Goddard
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