Krystal Biotech’s B-VEC Gets Priority Review

The FDA has granted a Priority Review to Krystal Biotech’s Biologics License Application (BLA) for its investigational gene therapy B-VEC for patients with the rare skin disease dystrophic epidermolysis bullosa.

B-VEC delivers gene copies designed to produce a collagen protein (COL7) that is lacking in patients with the condition, which causes the skin to be very fragile and to blister easily.

The gene therapy has received Orphan Drug designation, Fast Track designation, Rare Pediatric Disease designation and Regenerative Medicine Advanced Therapy designation from the FDA. The agency has set a decision date of Feb. 17, 2023 on the BLA.

Krystal Biotech plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.