(RTTNews) - Abeona Therapeutics (ABEO) announced the FDA has accepted for review resubmission of Biologics License Application for prademagene zamikeracel, its investigational autologous cell-based gene therapy, as a potential new treatment for recessive dystrophic epidermolysis bullosa. The FDA has assigned a PDUFA target action date of April 29, 2025.
The BLA resubmission is supported by clinical efficacy and safety data after a one-time administration of pz-cel from the pivotal Phase 3 VIITAL study and a Phase 1/2a study with up to 8 years of follow-up.
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