Abeona Therapeutics Says FDA Approved ZEVASKYN For Recessive Dystrophic Epidermolysis Bullosa

(RTTNews) - Abeona Therapeutics Inc. (ABEO) Tuesday said that the U.S. Food and Drug Administration (FDA) has approved ZEVASKYN, the first cell-based gene therapy for the treatment of wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB), a serious and debilitating genetic skin disease.

There is no cure for RDEB and ZEVASKYN is the only FDA-approved product to treat RDEB wounds with a single application, the company noted.

The approval is based on the Phase 3 VIITAL study that showed statistically significant healing of 50 percent or more from baseline in large chronic RDEB wounds, and pain reduction as evaluated at six months after treatment.