A new treatment for dystrophic epidermolysis bullosa (DEB) is one step closer following the recent news that B-VEC from Krystal Biotech Inc has been accepted for review by the US Food and Drug Administration (FDA).

B-VEC seeks to use gene therapy to treat all forms of DEB. It uses Krystal's STAR-D technology to deliver functional human COL7A1 genes directly to the skin of affected patients. The COL7A1 genes then express functional collagen VII to form anchoring fibrils stabilising the patient's otherwise fragile skin. The therapy is applied topically to DEB wounds.

The application has been granted Priority Review designation, which is reserved for applications that treat a serious condition and if approved could provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition.

Krystal Biotech plans to submit a marketing authorisation application to the European Medicines Agency (EMA) in the second half of 2022 which could pave the way for this treatment to be approved for use in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).

To find out more please read the full update from Krystal Biotech.