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VYJUVE® (beremagene geperpavec-svdt)

VYJUVEK® (beremagene geperpavec-svdt) (VYEJOO-VEK), developed by Krystal Biotech, is the first FDA-approved treatment to address the genetic cause of dystrophic Epidermolysis Bullosa (DEB).

The topical gel containing an HSV vector expressing a full-length, functional human COL7A1 enables skin cells to produce functional Collagen VII protein and promotes wound healing and skin stability.

VYJUVE® is approved as topical gel for dystrophic Epidermolysis Bullosa patients 6 months of age or older. Only a healthcare professional should apply VYJUVEK™ at a healthcare professional setting (I.e. clinic) or home setting, depending on your doctor’s instructions, your insurance plan coverage, and your preference.

Approved by Date of Approval Therapeutic Approach Route of Administration EB Subtype
FDA May 2023 Gene therapies and combined gene/cell therapies Topical DEB

Learn more about the drug.

Please note that a marketing authorisation by a national or international regulatory authority (European Medicines Authority [EMA], Food and Drug Administration [FDA] etc.) does not indicate whether the therapy or medication is available in a particular country or is reimbursed by a health insurance fund.

 

Related links

First gene therapy for DEB patients approved in the US - EB-Research (eb-researchnetwork.org)

Krystal Biotech B-VEC awaiting approval by FDA - EB-Research (eb-researchnetwork.org)

Krystal Biotech: Gene therapy gel submitted for approval in the U.S. - EB-Research (eb-researchnetwork.org)

Krystal announces positive Phase 3 results - EB-Research (eb-researchnetwork.org)

Krystal Phase 1/2 Publication in Nature - EB-Research (eb-researchnetwork.org)

 

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