Shots:
- The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2’25
- Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing successful COL7A1 gene delivery & durable wound closure after topical application
- Long-term safety & efficacy were supported by the US OLE trial & real-world data since Vyjuvek’s US launch in 2023
Ref: Krystal Biotech | Image: Krystal Biotech
Related News:- Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)
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