On 15 May 2026, the Medicines and Healthcare products Regulatory Agency approved beremagene geperpavec, marketed as Vyjuvek, for the treatment of wounds in patients with dystrophic epidermolysis bullosa. The approval, granted to Krystal Biotech Netherlands, B.V., covers use from birth onwards. For patients and clinicians, the immediate effect is regulatory clarity: the UK now has an authorised medicine specifically approved for DEB wounds. The MHRA said the product information, including the Summary of Product Characteristics and Patient Information Leaflet, will be published on its products website within seven days of approval.
Dystrophic epidermolysis bullosa is a rare genetic condition that leaves the skin fragile and prone to blistering because of a fault in a gene responsible for holding skin layers together, according to the MHRA. Wounds can be recurrent and difficult to manage, which is why a wound-focused approval is significant in practice. The age range is also important. Because the authorisation applies from birth onwards, the decision covers the point at which the condition may first present, as well as later childhood and adulthood.
Vyjuvek is supplied as a gel applied directly to wounds. The MHRA said the treatment works by delivering copies of the affected gene into cells in the wound to help the skin heal. The agency also addressed a point likely to matter to families and clinicians. It said the modified virus and genetic material in the medicine do not change the patient's DNA. That distinction helps explain the treatment as a wound-applied genetic medicine rather than a permanent alteration of the person's DNA.
The evidence cited in the MHRA announcement came from a study of 31 patients aged 1 to 44 years with dystrophic epidermolysis bullosa. After six months, 67% of wounds treated with beremagene geperpavec were completely healed, compared with 22% of wounds treated with placebo. The numbers are small, but that is typical in rare disease research. In this case, the gap in complete wound healing is the central efficacy signal behind the approval and the figure clinicians are most likely to focus on when assessing the decision.
Julian Beach, the MHRA's Executive Director of Healthcare Quality and Access, said the approval provides a new treatment option for patients living with dystrophic epidermolysis bullosa. He also said the agency will continue to monitor the safety and effectiveness of beremagene geperpavec as it is used more widely. That continuing oversight matters alongside the initial approval. The Patient Information Leaflet and the Summary of Product Characteristics will set out the reported side effects and formal conditions of use, giving clinicians, pharmacists and families the detailed information needed for treatment decisions.
The MHRA said the product was submitted and approved through the International Recognition Procedure. In plain English, that means the application moved through a UK route that can recognise parts of an international regulatory assessment while still ending in a UK approval. For the wider medicines policy picture, the case is notable because it combines a rare disease authorisation with that recognition route. For patients, the headline is simpler: the UK regulator has approved a new treatment for DEB wounds from birth onwards, with further safety monitoring to continue after approval.