FDA Approves Abeona’s ZEVASKYN as First Cell-Based Gene Therapy for RDEB
The FDA approved Abeona Therapeutics’ ZEVASKYN (prademagene zamikeracel, or pz-cel), the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB). ZEVASKYN is designed as a single-application surgical treatment using gene-corrected skin cell sheets to promote long-term healing in large, chronic wounds. The approval is based on data from the pivotal Phase III VIITAL study, which showed significant healing and pain reduction compared to standard care.
“This marks a pivotal moment for the RDEB community,” said Abe...
