FDA expands approval for ViiV's Dovato to teens with HIV

2024-04-08
临床3期上市批准临床结果
ViiV Healthcare announced on Monday that the FDA approved Dovato (dolutegravir/lamivudine) for the treatment of certain adolescents with HIV-1 infection, making it the first oral, two-drug, single-tablet HIV regimen available for people as young as 12 years old.
Specifically, Dovato is now indicated for adolescents weighing at least 25kg with no prior antiretroviral (ARV) treatment or to replace the current ARV regimen in individuals who are virologically suppressed on an ARV regimen.
The broader indication provides "a complete HIV therapy with fewer ARV medicines – an important consideration for young people who will require lifelong treatment," said Lynn Baxter, who heads ViiV's North America operations.
The label expansion was supported by data from the DANCE study, which evaluated Dovato in treatment-naïve adolescents as well as three Phase III trials in adults with HIV, GEMINI-1, GEMINI-2 and TANGO. Results from the DANCE study showed that 26 of 30 participants achieved and maintained viral suppression at week 48, with safety and efficacy data comparable to those seen in adults.
Dovato was initially approved in the US in 2019 for adults with treatment-naïve HIV. The drug also gained FDA approval the following year for use in virologcally suppressed adults with HIV.
更多内容,请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点,如有版权侵扰或错误之处,请及时联系我们,我们会在24小时内配合处理。
适应症
靶点
-
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台,助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台,以API或者数据包形式对外开放,助您更加充分利用智慧芽新药情报信息。