Pfizer can restart PhIII trial of Duchenne gene therapy, now on track for late-2023 FDA approval request
Pfizer’s path at getting a gene therapy to market for patients with Duchenne muscular dystrophy just got a little clearer after a hazy 2021 that saw a clinical hold, an amended late-stage trial and a patient death in an early-stage study.
US regulators will allow the Big Pharma to resume its Phase III study dubbed CIFFREO, Pfizer said Thursday morning, noting it has amended the protocol to assess patients in the hospital for seven days post-administration. The clinical hold lift follows reviews of data and protocol amendments, Pfizer added.
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