Department of Medicine, Weill Cornell Medicine, 525 East 68th Street, New York, NY, 10065, USA.
Drugs R D. 2022 Mar;22(1):9-13. doi: 10.1007/s40268-021-00376-x. Epub 2021 Dec 27.
On 2 June, 2021, the US Food and Drug Administration approved ibrexafungerp (formerly MK-3118 and SCY-078) for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. Ibrexafungerp is the first drug approved in a novel antifungal class in more than two decades, and the Food and Drug Administration's decision was based on positive results from two pivotal phase III studies in which oral ibrexafungerp proved both safe and effective in patients with vulvovaginal candidiasis. The decision was also based on substantial preclinical and clinical work in both the pharmacokinetics and pharmacodynamics of ibrexafungerp. This paper reviews that research and looks ahead to explore how this novel antifungal agent may be used in the future to address the expanding problem of drug-resistant mycotic infections.
2021 年 6 月 2 日，美国食品和药物管理局批准了伊布列康唑（曾用名 MK-3118 和 SCY-078）用于治疗外阴阴道念珠菌病，也称阴道酵母菌感染。伊布列康唑是二十多年来首个获批的新型抗真菌药物类别，食品和药物管理局的这一决定基于两项关键性 III 期研究的积极结果，研究显示口服伊布列康唑治疗外阴阴道念珠菌病安全且有效。这一决定还基于伊布列康唑的药代动力学和药效学的大量临床前和临床研究。本文回顾了该研究，并展望了未来如何使用这种新型抗真菌药物来解决日益严重的耐药真菌感染问题。
