VYJUVEK® (beremagene geperpavec-svdt) DEB Treatment
VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB). VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not …
FDA Approves First Topical Gene Therapy for Treatment of …
2024年10月1日 · Today, the U.S. Food and Drug Administration approved Vyjuvek, a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy, for the treatment of wounds in patients 6 months of age and older...
可重复使用的基因疗法“外用药膏”获批后，基因治疗滴眼液和除皱 …
2023年5月30日 · 基因疗法是一个充满潜力的领域，自2017年以来，美国FDA已经批准了5种罕见遗传病的基因疗法，近期Krystal Biotech旗下可“重复使用的”基因疗法Vyjuvek的 获批 再次刷新了这一数据。 Vyjuvek的获批上市无疑是一个里程碑，它创造了多个“首次”—— 它是首个FDA批准的外用基因疗法，也是首款可重复给药的基因疗法。 同时，它为营养不良性大疱性表皮松解症（DEB）患者带来了首款获批的基因疗法。 DEB是一种罕见且严重的单基因遗传病， 由编 …
VYJUVEK | FDA - U.S. Food and Drug Administration
2023年8月7日 · Indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with mutation (s) in the collagen type VII alpha 1 chain (COL7A1) gene.
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa with...
Vyjuvek | European Medicines Agency (EMA)
As Vyjuvek is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the Committee for Advanced Therapies. The applicant for this medicinal product is Krystal Biotech Netherlands, B.V. Vyjuvek will be available as 5 x 10⁹ plaque forming units/ml suspension and gel for gel.
Learn More About VYJUVEK® (beremagene geperpavec-svdt)
VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB). VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not …
里程碑！首款可“重复使用”的基因疗法获FDA批准_腾讯新闻
2023年5月20日 · Vyjuvek是一款现货型（off-the-shelf）外用基因疗法，旨在为患者的皮肤细胞提供两个COL7A1基因的正常拷贝，生成功能性VII型胶原蛋白（COL7）蛋白，针对导致疾病的根本机制进行治疗，这款基因疗法通过基因工程改造的HSV-1载体来进行基因递送。 HSV-1是一种双链DNA病毒，它的基因组完全以染色体外（episomal）形式存在，其大小可以轻松容纳大型或多个基因，并且它可以转导分裂和非分裂的细胞，不会整合到宿主细胞基因组中，也不会以其他方式 …
Dosing & Administration | VYJUVEK® (beremagene geperpavec …
VYJUVEK is a topical gel used to treat wounds in patients 6 months and older with dystrophic epidermolysis bullosa (DEB). VYJUVEK gel must be applied by a healthcare provider. After treatment, patients and caregivers should be careful not …
Revolutionary breakthrough: FDA approves Vyjuvek, the first …
Vyjuvek is the first topical gene therapy for DEB, utilizing a genetically modified HSV-1 (herpes simplex virus 1) vector to express human COL7 and promote wound healing. Clinical trials have shown that Vyjuvek increases the probability of complete wound healing compared to placebo.