US approves PONVORY for relapsing multiple sclerosis

US regulators have approved PONVORY (ponesimod), Janssen’s once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.

PONVORY offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.

The FDA approval is based, in part, on a two-year, head-to-head Phase 3 clinical trial in which PONVORY 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide (Aubagio) 14 mg in patients with relapsing MS.3 Over the study period, 71% of patients treated with PONVORY™ had no confirmed relapses, compared to 61% in the teriflunomide group.

PONVORY was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively. GdE T1 lesions and T2 lesions are identified using magnetic resonance imaging (MRI) technology and are recognized as classic measures of MS pathology that can provide insights into disease activity and disease burden, respectively.

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