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Krystal Biotech

Krystal Biotech’s Vyjuvek (Beremagene Geperpavec-svdt) Receives the EC’s Approval for Dystrophic Epidermolysis Bullosa (DEB)

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…

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Krystal Biotech

Krystal Biotech’s Vyjuvek (beremagene geperpavec) Receives the CHMP’s Positive Opinion for Dystrophic Epidermolysis Bullosa (DEB)

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)…

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