ViiV Healthcare wins FDA approval for Tivicay PD in pediatric HIV patients weighing at least 2 kg

PUBT · 3d ago
ViiV Healthcare wins FDA approval for Tivicay PD in pediatric HIV patients weighing at least 2 kg
  • GSK affiliate ViiV Healthcare secured FDA clearance for Tivicay PD to treat HIV-1 in children weighing at least 2 kg.
  • Decision extends dolutegravir-based therapy to eligible newborns from birth, broadening ViiV’s pediatric HIV market reach in the U.S.
  • Label covers treatment-naïve patients or treatment-experienced but INSTI-naïve patients, used with other antiretroviral agents.
  • Authorization supported by NIH-funded IMPAACT 2023 data, supported by pharmacokinetic modeling showing therapeutic levels in term neonates.


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