Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan
Shots:
- The NDA submission is based on FIREFISH study assessing Risdiplam in infants with symptomatic SMA Type 1 & SUNFISH study in children and young adults with SMA Type 2 or 3
- FIRESISH study results: improvement in survival and motor milestones in infants. SUNFISH study results: improvement in motor function in people aged 2-25 with type 2 or 3 SMA
- Risdiplam (PO) is a therapy designed to increase and sustain SMN protein levels in the CNS & throughout the body. The therapy has received MHLW’s ODD on Mar 27- 2020- and is a subject to PR in Japan
Ref: Chugai | Image: Financial Times
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