The US FDA Delays its Decision on Roche’s Risdiplam for the Treatment of Spinal Muscular Atrophy

Shots:

  • The US FDA has extended the PDUFA date for its review of risdiplam’s NDA with the expected decision by Aug 24, 2020. The extension is based on the submission of additional data, including SUNFISH Part 2 study
  • The company has submitted filing applications for in seven countries with submission in China imminent and currently on track submit an MAA to the EMA in mid-2020 and other international markets               
  • In Nov’2019, the FDA granted PR for with a decision for approval expected by May 24, 2020. In Feb’2020, Roche has submitted some additional data which ensure access to the therapy for a broad range of people living with the condition, if approved

Click here ­to­ read full press release/ article | Ref: Roche | Image: Pantone Canvas Gallery