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Abeona’s ZEVASKYN Gets FDA Nod for Rare Skin Disease

The FDA approval of ZEVASKYN is based on the pivotal Phase 3 VIITAL study.

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By: Charlie Sternberg

Associate Editor

The U.S. Food and Drug Administration (FDA) has approved Abeona Therapeutics Inc.’s ZEVASKYN (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, as the first and only autologous cell-based gene therapy for the treatment of wounds in adult and pediatric 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...

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