Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

October 16, 2020 Auto Bot Chugai, drug, First, Japan, MHLW, NDA, regulatory, Report, Risdiplam, spinal muscular atrophy 0

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

Click here ­to­ read full press release/ article | Ref: Chugai | Image: Financial Times

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