A committee of the European Medicines Agency is recommending approving Vyjuvek (beremagene geperpavec), a gene therapy from Krystal Biotech, to treat wounds in patients of all ages with dystrophic epidermolysis bullosa (DEB). The opinion by the Committee for Medicinal Products for Human Use (CHMP) will now go to…

An arm of the European Medicines Agency (EMA) is expected to issue its opinion early next year on whether to approve beremagene geperpavec-svdt, which is marketed as Vyjuvek in the U.S., for dystrophic epidermolysis bullosa (DEB). The Committee for Medicinal Products for Human Use (CHMP) has asked Krystal…

The just-approved gene therapy Vyjuvek (beremagene geperpavec) soon will be available to people with dystrophic epidermolysis bullosa (DEB) in the U.S. at home and in the clinic. Krystal Biotech, the treatment’s developer, has set up a limited distribution network in the country that includes Option Care Health…

The U.S. Food and Drug Administration (FDA) has approved Vyjuvek (beremagene geperpavec), Krystal Biotech’s gene therapy gel, for treating skin wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB). Vyjuvek becomes the first re-dosable gene therapy approved by the FDA, and the only medicine approved…

The U.S. Food and Drug Administration (FDA) has delayed by three months its review deadline for Krystal Biotech’s gene therapy gel Vyjuvek (beremagene geperpavec) for dystrophic epidermolysis bullosa (DEB). The decision on Krystal’s application for approval of Vyjuvek, previously expected by mid-February this year, has been…

Krystal Biotech’s gene therapy gel Vyjuvek (beremagene geperpavec) for dystrophic epidermolysis bullosa (DEB) has been granted priority review by the U.S. Food and Drug Administration (FDA). Priority review status is expected to shorten the review process for applications to six months from the standard 10 months. A decision…

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 —…

Vyjuvek, a gene therapy gel (previously called B-VEC) by Krystal Biotech, safely and effectively improved wound healing in children and adults with recessive dystrophic epidermolysis bullosa (RDEB), according to data from a Phase 1/2 clinical trial. Importantly, resolved wounds remained closed for at least three months and up to eight…

Treatment with Vyjuvek (previously called B-VEC) — a topical gene therapy for dystrophic epidermolysis bullosa (DEB) — improved wound healing with good tolerability over six months, according to top-line results of the Phase 3 GEM-3 trial. “We are thrilled to announce positive results from our pivotal GEM-3 trial of VYJUVEK…