The US Food and Drug Administration (FDA) has approved Zevaskyn, the first cell-based gene therapy for a rare genetic skin disorder called recessive dystrophic epidermolysis bullosa.
Developed by Abeona Therapeutics, Zevaskyn is designed for both adults and children with this condition, which causes extremely fragile skin, painful blisters, and wounds that are hard to heal.
The disorder is caused by a defect in the COL7A1 gene, which stops the body from making a key type of collagen needed to keep skin layers together. Until now, patients have relied on daily wound care and protective bandages.
Zevaskyn works by adding healthy COL7A1 genes to a patient’s skin cells, which are then grafted back onto the body to help heal chronic wounds. The FDA’s approval was based on studies showing the therapy significantly improved wound healing and reduced pain.
The treatment is expected to be available at select sites in the US by the third quarter of 2025. It will join Krystal Biotech’s Vyjuvek, another gene therapy approved in 2023 for smaller wounds. Experts say using both treatments together could help patients manage the disease more effectively.
Abeona’s shares rose 13% after the news, and analysts estimate Zevaskyn could reach peak sales of $427 million by 2034, with each treatment round expected to cost $1.75 million.
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