The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Vyjuvek for the treatment of wounds in patients suffering from Dystrophic Epidermolysis Bullosa (DEB), a rare genetic skin disorder that causes severe skin fragility and blistering. The approval was granted on May 15, 2026, to Krystal Biotech Netherlands B.V. through the International Recognition Procedure (IRP).

DEB is caused by mutations in a gene responsible for binding skin layers together, resulting in fragile skin that tears and blisters easily. Vyjuvek works by delivering functional copies of the faulty gene directly into wound cells, helping the skin repair and heal. According to the MHRA, the modified virus and genetic material used in the therapy do not alter the patient’s DNA.

The therapy is administered as a topical gel applied directly to wounds and has been approved for use in patients from birth onwards.

Clinical data supporting the approval came from a study involving 31 patients aged between 1 and 44 years with dystrophic epidermolysis bullosa. Results showed that 67 percent of wounds treated with Vyjuvek were completely healed after six months, compared to 22 percent of wounds treated with a placebo.

Julian Beach, Executive Director of healthcare quality and access at the MHRA, said the approval offers a new treatment option for patients living with DEB, a condition associated with fragile skin and recurring wounds. He added that the agency would continue monitoring the medicine’s safety and effectiveness as its use expands.

The MHRA noted that detailed information regarding potential side effects and safety guidance is available through the patient information leaflet and summary of product characteristics published on its website.

The MHRA, an executive agency of the UK Department of Health and Social Care, regulates medicines and medical devices in the United Kingdom to ensure they are safe, effective and meet quality standards.