Krystal Biotech, Inc. KRYS submits biologics license application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of B-VEC (beremagene geperpavec) in the treatment of patients with dystrophic epidermolysis bullosa (DEB).
The BLA submission for B-VEC is supported by data readout from the GEM-3, a multi centre trial and the GEM-1/2, a single-center trial, designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB.
Suma Krishnan, President of Research & Development, commented : “The unmet medical need for DEB patients remains very high and our relentless pursuit of a treatment for this disease continues with the same sense of urgency that we have always had since the founding of Krystal Biotech. We look forward to working with the FDA in its review of our BLA submission.”
The Company planning to submit a marketing authorization application to the European Medical Agency (EMA) in the second half of 2022.
B-VEC was granted fast track designation and rare pediatric designation by the FDA, in addition to EMA’s orphan drug designation and PRIority MEdicines (PRIME) eligibility for the treatment of DEB.
Krystal Biotech shares are trading high 7 percent at $65.08 in the regular session.