MHRA approves beremagene geperpavec gene therapy gel for DEB from birth

Published: 18-May-2026
Regulatory

The MHRA has approved beremagene geperpavec (Vyjuvek), a topical gene therapy gel for wounds in patients with dystrophic epidermolysis bullosa (DEB), for use from birth onwards

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved Krystal Biotech's beremagene geperpavec (Vyjuvek) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB).

The gel can now be applied directly to patients' wounds from birth onwards.

DEB is a rare genetic condition that causes the skin to be fragile and prone to blistering due to a mutation in a gene that helps hold skin layers together.

Beremagene geperpavec works by introducing a correct copy of the faulty gene into the cells of the wound, promoting skin healing.

The decision was based on a study showing 67% complete wound healing at six months, compared with 22% for placebo, in patients aged one to 44 years.

Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said: "This approval provides a new treatment option for patients living with dystrophic epidermolysis bullosa, a rare genetic condition that can cause fragile skin and recurrent wounds."

As with all medicines, we will continue to closely monitor the safety and effectiveness of beremagene geperpavec as it is used more widely.

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