FDA approves Abeona’s Zevaskyn

The US Food and Drug Administration (FDA) has approved Zevaskyn (prademagene zamikeracel) gene-modified cellular sheets, also known as pz-cel, from US gene therapy developer Abeona Therapeutics (Nasdaq: ABEO).

As a result, according to Abeona, Zevaskyn becomes 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.

However, Abeona will still face competition from Krystal Biotech’s (Nasdaq: KRYS) Vyjuvek (beremagene geperpavec-svdt), which gained FDA approval in 2023 for a similar indication.