Pfizer to Initiate P-III Study of Fordadistrogene Movaparvovec After FDA Lift Clinical Hold
Shots:
- Pfizer plans to open the first US sites in the P-III (CIFFREO) study evaluating fordadistrogene movaparvovec, in ambulatory patients with DMD
- The study was paused in Dec 2021 to implement a protocol amendment following a fatal SAEs that occurred in a P-Ib study in the non-ambulatory cohort
- Regulatory authorities in the UK, Canada, Taiwan, Spain and Belgium approve the re-start of the global P-III CIFFREO study and additional reviews are ongoing. The company anticipates all CIFFREO sites will open by the end of June 2022
Ref: Pfizer | Image: Pfizer
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