The USFDA has granted priority review designation to ViiV Healthcare's dolutegravir as a candidate with the potential to treat HIV infection in combination with other antiretroviral agents, in adolescents and adults.
The dolutegravir new drug application earlier submitted to the US agency included results from four pivotal phase III trials conducted in a total of 2553 HIV/AIDS patients.
ViiV Healthcare, established by GlaxoSmithKline and Pfizer, has also previously submitted dolutegravir marketing authorisation application to the European Medicines Agency.
Dolutegravir, an integrase inhibitor, is also known as S/GSK1349572 or just 572.