Krystal Biotech Receives FDA Approval for VYJUVEK™ (beremagene geperpavec-svdt)
Saturday, May 20, 2023
Krystal Biotech announced the US Food and Drug Administration (FDA) has approved VYJUVEK™ (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with dystrophic epidermolysis bullosa (DEB).
VYJUVEK is designed to address the genetic root cause of DEB by delivering functional copies of the human COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.
VYJUVEK is the first-ever redosable gene therapy and the first and only medicine approved by the FDA for the treatment of DEB, both recessive and dominant, that can be administered by a healthcare professional in either a healthcare professional setting or in the home.
Until now, doctors and nurses had no way to stop blisters and wounds from developing on dystrophic EB patient skin and all they could do was to give bandages and helplessly watch as new blisters formed.
VYJUVEK topical gene therapy changes all of this. VYJUVEK both heals patient wounds and prevents skin from re-blistering because it actually corrects the underlying skin defect of dystrophic EB. Because it’s safe and easy to apply directly to wounds, it doesn't require a lot of supporting technology or specialised expertise.
