FDA approves Krystal Biotech's VYJUVEK gene therapy for DEB; first redosable gene therapy

Krystal Biotech, Inc.

FDA approval of VYJUVEK (beremagene geperpavec-svdt) for dystrophic epidermolysis bullosa (DEB) patients aged 6 months+.
Phase 3 GEM-3 trial met primary endpoint of complete wound healing at six months and key secondary endpoint at three months.
First-ever redosable gene therapy approved and first FDA-approved medicine for DEB (both recessive and dominant).
Rare Pediatric Disease Priority Review Voucher granted by FDA.
U.S. commercial launch expected Q3 2023; EU filing planned H2 2023, Japan launch targeted 2025.

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