Krystal Seeks FDA Approval of Vyjuvek Gene Therapy Gel for DEB

 

Patricia Inácio, PhD

 

Krystal Biotech is seeking U.S. Food and Drug Administration (FDA) approval of Vyjuvek (previously called B-VEC), its topical gene therapy for people with dystrophic epidermolysis bullosa (DEB). The request was made in the form of a biologics license application or BLA — a type of marketing approval — supported by data from two clinical trials that showed that Vyjuvek healed DEB wounds and kept them closed. “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,” Suma Krishnan, president of research and development … read more