The U.S. FDA Approves ZEVASKYN™ for RDEB
We’re thrilled to share an exciting milestone for the Epidermolysis Bullosa (EB) Community: ZEVASKYN™, formerly known as pz-cel, the first-ever cell-based gene therapy skin graft for Recessive Dystrophic Epidermolysis Bullosa (RDEB), has been officially approved in the United States by the U.S. FDA!
Developed by Abeona Therapeutics, ZEVASKYN offers an innovative new treatment option for individuals and families affected by this devastating condition, bringing the potential for lasting wound healing and improved quality of life.
Here’s how ZEVASKYN™ works: Doctors take a small sample of a patient’s skin cells and modify them to include a healthy copy of the gene responsible for making Type VII collagen. These repaired cells are then grown into thin sheets and applied to the patient’s open wounds. Each treatment can use up to 12 sheets—each about the size of a credit card—offering real coverage and long-lasting results across affected skin.
This breakthrough didn’t happen overnight. ZEVASKYN was studied in multiple clinical trials, with some participants followed for up to eight years. Thanks to their bravery, and the tireless work of researchers, advocates, and families, this therapy is now a reality.
Importantly, ZEVASKYN’s approval marks a powerful collaboration between Abeona Therapeutics and debra of America.
“The FDA approval of ZEVASKYN underscores the vital and long-standing collaboration between Abeona Therapeutics and debra of America, as well as our shared commitment to improving the lives of individuals and families affected by RDEB,” said Vish Seshadri, Chief Executive Officer of Abeona. “We express our gratitude to debra for their unwavering support throughout the development journey that helped make regulatory approval possible. In particular, for their interactions with the FDA in support of ZEVASKYN and on behalf of the EB community, helped the FDA understand both the profound unmet need for innovative treatments to durably heal RDEB wounds and clinically meaningful endpoints for ZEVASKYN."
“This is a powerful moment for our community,” said Brett Kopelan, Executive Director of debra of America. “For decades, families affected by EB have dreamed of a day when real treatment options would exist—and today, ZEVASKYN makes three. ZEVASKYN is more than a therapy; it’s a symbol of what can happen when science, advocacy, and perseverance come together.”
ZEVASKYN is expected to become available in the U.S. starting in the Fall of 2025 through select Qualified Treatment Centers (QTCs), specialized hospitals and clinics experienced in advanced EB care.
To support our EB families through the treatment process, Abeona is launching Abeona Assist™, a patient support program that offers personalized guidance, resources, and information. Families can get in touch by calling 855-ABEONA-1 (855-223-6621) or emailing MyNavigator@AbeonaAssist.com.
We at debra of America are proud to have stood beside Abeona throughout this journey—from early trials to advocacy—to ensure that the voices of the EB Community were heard every step of the way.
