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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Ref: J&J | Image: Janssen
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