On February 28, 2025, the European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union (EU) for Vyjuvek (beremagene geperpavec) to treat wounds in patients of all ages with dystrophic epidermolysis bullosa (DEB).
Vyjuvek introduces a novel approach by utilizing a genetically modified herpes-simplex virus to deliver a functional COL7A1 gene directly to the wounds. Applied topically once a week, this therapy has demonstrated significant efficacy in clinical trials. In a study involving 31 patients, 71% of wounds treated with Vyjuvek achieved complete healing at three months, and 67% at six months, compared to 20% and 22% in the placebo group, respectively.
Common side effects reported include cough, runny nose, itching, redness, rash, and chills. Despite these, the benefits of Vyjuvek are considered to outweigh the risks, marking a promising development for DEB patients.
Vyjuvek's journey has been supported by EMA's PRIority MEdicines (PRIME) scheme, which offers early and enhanced scientific and regulatory support for medicines addressing unmet medical needs. With this positive recommendation, Vyjuvek is on the path to becoming the first approved topical gene therapy for DEB in the European Union, offering hope to patients and families affected by the challenges of DEB.
Read more about the recommendation on EMA's website here.
댓글