Jun 30 2022 Krystal seeks FDA approval of B-VEC for DEB
Last week, Krystal Biotech announced its submission of a Biologics License Application to the US Food and Drug Administration (FDA) seeking approval of B-VEC for the treatment of dystrophic epidermolysis bullosa (DEB).
B-VEC is a non-invasive, topical gene therapy, applied to DEB wounds, providing the patient’s skin with two copies of the COL7A1 gene to make functional Collagen VII. DEB is caused by mutations in the COL7A1 gene.
The submission was supported by data from two placebo-controlled trials (GEM-1/2 and GEM-3).
In addition to the FDA submission, the company anticipates submission of a European Medicines Agency marketing authorisation application in the second half of this year.
Read more on Krystal Biotech’s website.