Krystal Biotech Gets European Commission Approval For VYJUVEK® To Treat Dystrophic Epidermolysis Bullosa

Krystal Biotech, Inc. announced that on April 23, 2025, the European Commission (EC) granted marketing authorization for VYJUVEK® (beremagene geperpavec-svdt) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) who have mutations in the collagen type VII alpha 1 chain (COL7A1) gene, from birth. VYJUVEK is designed to address the genetic cause of DEB by delivering working copies of the COL7A1 gene, helping promote wound healing and sustained production of functional type VII collagen protein through repeated dosing. It is the first approved corrective treatment for DEB in Europe.

The EC's approval allows VYJUVEK to be marketed across all European Union member states, as well as Iceland, Norway, and Liechtenstein. Patients will have the flexibility to receive VYJUVEK either at home or in healthcare settings, with administration by either healthcare professionals, patients, or caregivers, depending on what is considered appropriate by medical staff. The timing for VYJUVEK’s availability in each country will vary based on reimbursement procedures, and Krystal Biotech plans to launch VYJUVEK first in Germany by mid-2025.

Laurent Goux, Senior Vice President and General Manager of Europe at Krystal Biotech, stated, “Today’s approval is an exciting milestone for Krystal and the patients we aim to serve. After years of preparation in close coordination with leading DEB treatment centers, we are ready and excited to bring this urgently needed therapy to patients. With already 1,000 DEB patients identified in France and Germany, as well as many more across the continent, our goal is clear – to ensure as many patients as possible are able to benefit from sustainable access to VYJUVEK.”

Suma Krishnan, President of Research and Development at Krystal Biotech, “We are delighted that VYJUVEK has been approved in Europe as a safe and effective therapy for the many patients across Europe suffering from DEB. This approval marks a critical milestone in our commitment to improving the lives of DEB patients around the world, and we look forward to providing patients in Europe with the first corrective medicine for this debilitating disease.”

This decision follows the positive recommendation issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in February 2025. The approval is supported by a full clinical dataset, including results from Krystal’s Phase 1/2 GEM-1 and Phase 3 GEM-3 clinical trials, which demonstrated successful delivery of the COL7A1 gene and durable wound closure after topical application. Additional support came from the company’s open-label extension study and real-world use data from the United States.

VYJUVEK had earlier been approved by the U.S. Food and Drug Administration (FDA) in May 2023 and is currently under review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), with a decision expected in the second half of 2025. VYJUVEK is based on a herpes-simplex virus type 1 (HSV-1) vector and is indicated for the treatment of DEB-related wounds in patients from birth who have mutations in the COL7A1 gene.