Janssen Reports Submission of Ponesimod’s NDA to the US FDA for the Treatment of Relapsing Multiple Sclerosis

Janssen Reports Submission of Ponesimod’s NDA to the US FDA for the Treatment of Relapsing Multiple Sclerosis

Shots:

  • The NDA is based on P-III OPTIMUM study assessing ponesimod (20mg) vs Aubagio (teriflunomide, 14 mg) in patients with relapsing MS
  • The P-III OPTIMUM study results: reduction in ARR (30.5%); reduction in CUALs (56%); reduction in fatigue symptoms; safety profile is consistent with the previous studies
  • Ponesimod is an investigational S1P1 modulator, act by inhibiting the S1P protein activity and has the potential to reduce the number of circulating lymphocytes crossing BBB

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