Abeona Therapeutics: FDA Grants Priority Review For Pz-cel BLA

(RTTNews) - Abeona Therapeutics Inc. (ABEO) announced the FDA has accepted and granted Priority Review for the Biologics License Application for pz-cel, the company's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic epidermolysis bullosa. Under the PDUFA, the FDA has set a target action date of May 25, 2024. The FDA does not currently plan to convene an Advisory Committee meeting to discuss the pz-cel application.

Abeona Therapeutics noted that the grant of the Priority Review status is an important prerequisite for its eligibility for a Priority Review Voucher. The BLA is supported by clinical efficacy and safety data from the Phase 3 VIITAL study and confirmatory evidence from a Phase 1/2a study.

For More Such Health News, visit rttnews.com.