FDA Approves Zevaskyn for Rare, Genetic Skin Disorder

Abeona prices rare cell disorder gene therapy at $3.1m

Abeona Therapeutics' Zevaskyn has been approved in the US as a treatment for the rare skin disorder recessive dystrophic epidermolysis bullosa (DEB).

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…

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…

FDA Approves First Cell-Based Treatment for Rare Skin Disorder

The Food and Drug Administration (FDA) has approved Zevaskyn, a gene therapy for a rare skin disorder, the company that makes the product said on April 29. Regulators approved Zevaskyn for adults and children with recessive dystrophic epidermolysis bullosa, a disorder that leaves skin fragile and prone to blistering. Severe cases of the disorder can result in loss of vision and other serious medical issues, according to the National Library of M…