Gene Therapy Revolution: Zevaskyn Cleared by FDA 

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Gene Therapy Revolution: Zevaskyn Cleared by FDA 
Gene Therapy Revolution: Zevaskyn Cleared by FDA 

United States: The US Food and Drug Administration licensed Zevaskyn as a gene therapy produced by Abeona Therapeutics for recessive dystrophic epidermolysis bullosa (RDEB) treatment of this rare genetic skin condition. Zevaskyn represents a major advancement in both regenerative medicine and gene therapy domains, as reported by Reuters. 

What Is RDEB? 

The mutated COL7A1 gene in RDEB patients stops their body from making type VII collagen thus causing the disease. Fragile skin develops from a lack of bonding between the upper and lower layers of skin because collagen deficiency prevents them from connecting correctly leading to continuous open wounds after minimal skin injuries. 

How Zevaskyn Works 

Zevaskyn uses a cell-based gene therapy method called pz-cel, where skin cells are modified to express healthy COL7A1 genes. These gene-corrected cells are then grafted onto the patient’s skin to promote healing of large, persistent wounds. 

Treatment Cost and Availability 

Abeona priced Zevaskyn at $3.1 million per treatment, with market launch expected in Q3 2025 via select treatment centers. The company anticipates treating 10 to 14 patients in the first year. 

Market Potential and Combination Therapy 

Zevaskyn enters a growing therapeutic space alongside Krystal Biotech’s Vyjuvek, approved in 2023 for milder RDEB lesions. Experts, including Brett Kopelan from Debra of America, suggest that combining Vyjuvek and Zevaskyn could help transform RDEB from a fatal disease into a manageable chronic condition. 

Analysts forecast Zevaskyn could generate up to $427 million in annual revenue by 2034, even after royalty considerations, as reported by Reuters. 

FDA Approval Backed by Strong Data 

The FDA based its approval on clinical trial data showing significant wound closure and pain relief. Zevaskyn’s success reflects growing confidence in gene-modified cell therapies for rare genetic disorders.