FDA accepts Krystal Biotech's BLA for B-VEC with Priority Review; PDUFA Feb 2023

Krystal Biotech, Inc.

FDA accepted BLA for B-VEC (gene therapy) to treat dystrophic epidermolysis bullosa (DEB).
Granted Priority Review; PDUFA target action date set for February 17, 2023.
FDA stated it does not currently plan to hold an advisory committee meeting on this BLA.
B-VEC previously received Fast Track and Regenerative Medicine Advanced Therapy (RMAT) designations.
Company plans to submit marketing authorization application to EMA in H2 2022.

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