Krystal Biotech has secured marketing authorization from the European Commission for Vyjuvek, a groundbreaking gene therapy designed to treat dystrophic epidermolysis bullosa (DEB).

This approval follows favorable recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use, underscoring the therapy's potential impact.

Vyjuvek is notable for being the first corrective medicine approved for DEB in Europe, promoting wound healing and sustained expression of type VII collagen.

The therapy employs a herpes-simplex virus type 1 vector to deliver functional copies of the COL7A1 gene, effectively addressing the underlying genetic cause of DEB.

Clinical data from the Phase 1/2 GEM-1 and Phase 3 GEM-3 studies demonstrated effective gene delivery and durable wound closure, further validated by real-world data from the United States.

Vyjuvek offers flexible dosing options, allowing administration either at home or in healthcare facilities, enhancing accessibility for patients.

Currently approved in the United States, Vyjuvek is also under review by Japan’s Pharmaceuticals and Medical Devices Agency, with a decision anticipated in the latter half of 2025.

The European Commission's approval enables Vyjuvek to be marketed across all European Union member states, in addition to Iceland, Liechtenstein, and Norway.

Krystal Biotech plans to launch Vyjuvek in Germany by mid-2025, aiming to reach approximately 1,000 identified DEB patients in France and Germany.

The leadership at Krystal Biotech has expressed a strong commitment to enhancing the lives of DEB patients, highlighting the significance of this milestone in improving therapy accessibility.

Dystrophic epidermolysis bullosa is a genetic disorder marked by skin fragility and blistering due to mutations in the collagen type VII alpha 1 chain gene.