The U.S. FDA Accepts Pz-cel for Priority Review and Sets PDUFA Date

Big news from Abeona Therapeutics —The U.S. Food and Drug Administration has granted Priority Review for the Biologics License Application for Pz-cel (prademagene zamikeracel), which means that they are fast-tracking their decision on whether to approve it. The FDA is aiming to make that decision by May 25, 2024, as part of a process called the Prescription Drug User Fee Act (PDUFA). 

Pz-cel is Abeona’s investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). It has demonstrated promising results in their Phase 3 VIITAL™ and Phase 1/2a trials, showing that the application of pz-cel once on large and chronic wounds helped them heal and reduced pain. 

Brett Kopelan, Executive Director of debra of America, shares, “We would like to congratulate Abeona on achieving this milestone and thank them for their commitment to the EB Community. We look forward to the FDA’s decision on May 25.” 

This exciting development brings us one step closer to another potential treatment for EB! Back in May 2023, the FDA approved VYJUVEK ™, a topical gel to treat Dystrophic EB in patients 6 months and older.

For more information, read the Abeona Therapeutics press release.