Abeona's Gene Therapy Zevaskyn Approved by FDA for Rare Skin Disease

Keywords

• Zevaskyn (prademagene zamikeracel)
• Recessive dystrophic epidermolysis bullosa (RDEB)
• Autologous cell-based gene therapy
• $3.1 million price tag
• FDA approval (April 29, 2025)
• COL7A1 gene
• Chronic wound treatment

Key Facts

The U.S. Food and Drug Administration (FDA) has approved Abeona Therapeutics' Zevaskyn (prademagene zamikeracel), the first and only autologous cell-based gene therapy for treating wounds in patients with recessive dystrophic epidermolysis bullosa (RDEB)1. This approval comes after the FDA initially rejected Abeona's application last year due to manufacturing and quality control concerns24.

Zevaskyn works by using the patient's own keratinocytes, which are harvested, genetically modified to express the functional COL7A1 gene, and surgically applied to chronic wounds as credit card-sized sheets of skin2. The therapy addresses the underlying cause of RDEB, a condition where patients lack the collagen essential for anchoring skin layers together due to genetic mutations2.

The therapy is priced at $3.1 million, placing it among the most expensive treatments in the U.S., though this pricing is consistent with other rare disease gene and cell therapies2. Abeona plans to launch Zevaskyn commercially in the third quarter of 2025 through qualified treatment centers across the United States23.

Abeona received a rare pediatric disease priority review voucher alongside the FDA approval, which the company plans to monetize3. The approval positions Abeona as the second company to bring an RDEB therapy to market, following Krystal Biotech's Vyjuvek, which was approved in May 2023 and has generated over $341 million since its launch34.

Sources:

1. https://investors.abeonatherapeutics.com/press-releases/detail/303/u-s-fda-approves-zevaskyn-prademagene-zamikeracel

2. https://www.pharmaceutical-technology.com/news/fda-approves-abeonas-3-1m-cell-therapy-for-rare-skin-disease/

3. https://www.fiercepharma.com/pharma/abeona-enters-commercial-gene-therapy-arena-fda-nod-zevaskyn-treat-rare-genetic-skin-disease

4. https://www.cgtlive.com/view/fda-approves-abeona-therapeutics-epidermolysis-bullosa-gene-therapy-pz-cel