ViiV Healthcare wins FDA approval for Tivicay PD in pediatric HIV patients weighing at least 2 kg
GSK•FDA clears Tivicay PD for pediatric HIV patients
ViiV Healthcare, a GSK affiliate, said it secured FDA clearance for Tivicay PD to treat HIV-1 in children weighing at least 2 kg.
The decision extends dolutegravir-based therapy to eligible newborns from birth, broadening ViiV’s pediatric HIV market reach in the U.S.
The label covers treatment-naïve patients or treatment-experienced but INSTI-naïve patients, and the drug is used with other antiretroviral agents.
Authorization was supported by NIH-funded IMPAACT 2023 data, along with pharmacokinetic modeling showing therapeutic levels in term neonates.
