Shots:
- The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC’s decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025
- Opinion was based on various clinical data, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data published in Nature Medicine & The NEJM, respectively, 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
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