Vyjuvek
Opinion
EMA has issued an opinion on this medicine
beremagene geperpavec
MedicineHumanOpinion
Overview
On 27 February 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Vyjuvek, intended for the topical treatment of wounds in people with dystrophic epidermolysis bullosa caused by mutations in the collagen type 7 alpha 1 chain (COL7A1) gene. As Vyjuvek is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies.
The applicant for this medicinal product is Krystal Biotech Netherlands, B.V.
Vyjuvek will be available as 5 x 10⁹ plaque forming units/ml suspension and gel for gel. The active substance of Vyjuvek is beremagene geperpavec, a cicatrisant preparation for the treatment of wounds and ulcers (ATC code: D03AX16). Vyjuvek is a gene therapy based on a herpes simplex virus 1, genetically modified to be replication-defective and encode the COL7A1 gene. When the gel is applied to the wounds, it can transduce both keratinocytes and fibroblasts. Inside the nucleus of these cells, COL7A1 is transcribed without integration in the patient’s genome. The resulting transcripts allow for production and secretion of functional COL7 by the cells. COL7 proteins arrange themselves to form anchoring fibrils, which hold the epidermis and dermis together and are essential for maintaining the integrity of the skin.
The benefit of Vyjuvek is a higher rate of complete wound healing up to 6 months of treatment compared with placebo. The most common side effects are cough, rhinorrhoea, skin and subcutaneous tissue disorders (pruritus, erythema, rash), and chills.
The full indication is:
Vyjuvek is indicated for the treatment of wounds in patients with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene, from birth.
Vyjuvek should be initiated by healthcare professionals experienced in the management of patients with dystrophic epidermolysis bullosa.
Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.
Product details
- Name of medicine
- Vyjuvek
- Active substance
- Beremagene geperpavec
- International non-proprietary name (INN) or common name
- beremagene geperpavec
- Therapeutic area (MeSH)
- Epidermolysis Bullosa Dystrophica
- Anatomical therapeutic chemical (ATC) code
- D03AX16
- EMA product number
- EMEA/H/C/006330
Advanced therapy
This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.
Orphan
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
PRIME: priority medicine
This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.
- Marketing authorisation applicant
- Krystal Biotech Netherlands B.V.
- Opinion adopted
- 27/02/2025
- Opinion status
- Positive
News on Vyjuvek
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