FDA approval of Dovato for adolescents with HIV

Providing continuing competition to market leader Gilead Sciences (Nasdaq: GILD), ViiV Healthcare has achieved a new milestone in the HIV space.

The UK-based company, which is majority owned by pharma major GSK (LSE: GSK), with Pfizer and Shionogi as shareholders, has secured a new US Food and Drug Administration (FDA) approval for Dovato (dolutegravir/lamivudine).

This approval is for HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history, or to replace the current ARV regimen, in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato.