FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
- The U.S. Food and Drug Administration has approved Zevaskyn for treating recessive dystrophic epidermolysis bullosa, a rare genetic skin disorder.
- Zevaskyn is the first autologous cell-based gene therapy approved for this condition, which affects both adults and children.
- In a phase 3 VIITAL study, 81 percent of 43 large, chronic wounds showed 50 percent or greater healing after six months.
- Abeona Therapeutics received FDA approval for Zevaskyn, marking the third approval for treatments of this rare disorder in two years.
58 Articles
58 Articles
Butterfly Effect: FDA Approves Gene-edited Cell Therapy ZEVASKYN for Rare Skin Disease
Tissue paper. Cobwebs. Butterfly wings. This is the level of skin fragility experienced by patients with recessive dystrophic epidermolysis bullosa (RDEB), a condition that causes continuous blistering, excruciating wounds, and scarring that can cover more than 30% of the body surface and even up to 80% in extreme instances. Those who are born with a mutation in the COL7A1 gene, which codes for Type VII collagen, experience a life of constant ph…
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FDA Approves Zevaskyn for Rare, Genetic Skin Disorder
TUESDAY, April 29, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Zevaskyn (prademagene zamikeracel) for patients with the rare, genetic skin disorder recessive dystrophic epidermolysis bullosa.
FDA OKs New Gene Therapy for Debilitating Skin Condition
(MedPage Today) -- The FDA approved prademagene zamikeracel (Zevaskyn) for treating adults and children with the blistering wounds caused by recessive dystrophic epidermolysis bullosa (RDEB), Abeona Therapeutics announced on Tuesday. Patients...
FDA Approves Abeona Gene Therapy for Healing Wounds From Rare, Inherited Skin Disease
Abeona Therapeutics makes Zevaskyn by engineering a patient’s biopsied skin cells to express the collagen that they lack, then growing those cells into sheets that can be surgically applied to a wound. Abeona’s cell-based gene therapy is just the third FDA-approved treatment for epidermolysis bullosa, a rare disease that leads to skin described as thin and fragile like a butterfly’s wings. The post FDA Approves Abeona Gene Therapy for Healing Wo…
The Progress
Historic achievement: FDA approval of Abeona Therapeutics' ZEVASKYN accelerates momentum and expands treatment options for the EB community.
EB Research Partnership ("EBRP") invested in the work that led to ZEVASKYN at Stanford University under their pioneering Venture Philanthropy Model. This approval marks a historic moment for the EB community as the third FDA approved treatment and the first…
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