The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 15 May 2026, approved beremagene geperpavec (Vyjuvek) for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB). It can be used from birth onward.
DEB is a rare genetic condition that makes the skin fragile and prone to blistering due to a fault in a gene responsible for holding skin layers together.
Beremagene geperpavec works by copying of the faulty gene into the cells of the wound to help the skin heal. The modified virus and genetic material in this medicine do not change the patient’s DNA.
Beremagene geperpavec is a gel, applied directly to wounds.
In a study of 31 patients aged 1 to 44 years with dystrophic epidermolysis bullosa, beremagene geperpavec was shown to help heal wounds. At 6 months, 67% of wounds treated with the medicine were completely healed, compared with 22% of those treated with placebo.
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.”
For the full list of all side effects reported with this medicine, see Section 4 of the PIL or the SmPC available on the MHRA website.
Notes to editors
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The approval was granted on 15 May 2026 to Krystal Biotech Netherlands, B.V.
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This product was submitted and approved via International Recognition Procedure (IRP).
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More information can be found in the Summary of Product Characteristics and Patient Information Leaflets which will be published on the MHRA Products website within 7 days of approval.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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