Ponesimod NDA for Relapsing Multiple Sclerosis Submitted for Review

The New Drug Application (NDA) for ponesimod has been submitted to the FDA for the treatment of relapsing multiple sclerosis.

The New Drug Application (NDA) for ponesimod (Janssen) has been submitted to the Food and Drug Administration (FDA) for the treatment of relapsing multiple sclerosis.

Ponesimod is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that reduces the number of circulating lymphocytes that can cross the blood-brain barrier by inhibiting S1P protein activity. Movement of immune cells into the brain leads to demyelination in patients with multiple sclerosis, resulting in the neurological symptoms of the disease.

The NDA is supported by data from the OPTIMUM phase 3 trial, a head-to-head study that evaluated the efficacy of ponesimod vs teriflunomide, a pyrimidine synthesis inhibitor, in reducing annualized relapse rate (ARR). Results showed that at Week 108, treatment with ponesimod was associated with a statistically significant reduction of 30.5% on ARR when compared with teriflunomide. In addition, statistically significant reductions in fatigue symptoms and combined unique active lesions (both key secondary end points) were observed in the ponesimod group vs the teriflunomide group. 

“We were thrilled to see improvement in fatigue-related symptoms as part of the phase 3 OPTIMUM trial as we know the profound impact it may have on a person’s daily life,” said Husseini Manji, MD, FRCPC, Global Therapeutic Area Head for Neuroscience at Janssen Research & Development, LLC. “The improvement in fatigue, coupled with reduction in ARR, demonstrate great promise for ponesimod with patients seeking a more targeted treatment option.”

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With regard to safety, treatment-related adverse events were consistent with those seen in previous studies of ponesimod and other S1P receptor modulators (eg, fingolimod, siponimod).

For more information visit janssen.com.