ViiV Healthcare’s Tivicay PD gains FDA approval for paediatric HIV therapy
The US FDA has approved ViiV Healthcare’s Tivicay PD, for use with other antiretroviral agents in paediatric patients with HIV-1 who weigh at least 2 kg. The decision is backed by data from the IMPAACT 2023 clinical study and additional paediatric pharmacokinetic modelling. The studies indicated that dolutegravir reached therapeutic levels in neonates and showed a safety profile similar to older patients. Credit: Gorodenkoff/Shutterstock.com. The US Food and Drug Administration (FDA) has approved ViiV Healthcare’s Tivicay PD (dolutegravir), for use with other antiretroviral agents in paediatric patients with human immunodeficiency virus type 1 (HIV-1) who weigh at least 2kg. The…
The US FDA has approved ViiV Healthcare’s Tivicay PD, for use with other antiretroviral agents in paediatric patients with HIV-1 who weigh at least 2 kg.
Source: Pharmaceutical Technology