GlaxoSmithKline’s (GSK; NYSE: GSK) ViiV Healthcare has received an indication extension from the US Food and Drug Administration (FDA) for its antiretroviral treatment Dovato (dolutegravir + lamivudine). The drug is now approved for use in virologically suppressed or treatment-naive adolescents aged 12 years and older with HIV-1 infection, a demographic that represents a significant portion of new HIV diagnoses in the US. Originally indicated for adults, the once-daily single-tablet regimen has demonstrated safety and efficacy profiles in adolescents that are consistent with those observed in adult populations.
The FDA’s decision comes on the heels of positive results from a Phase IIIb trial, which showed that 26 out of 30 participants in the study achieved and maintained viral suppression at Week 48. This marks a significant advancement in the treatment options available for adolescents living with HIV, offering a simpler and potentially more effective treatment option.
The extension of Dovato’s indication to adolescents underscores ViiV Healthcare’s commitment to addressing the unmet needs of the HIV community, including hard-to-reach populations such as adolescents. This approval is a testament to the company’s ongoing efforts to develop and provide innovative treatment options that can improve the lives of people living with HIV.- Flcube.com