ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay

London – ViiV Healthcare, the global specialist HIV company majority owned by GSK, announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) to extend the use of Tivicay PD (dolutegravir (DTG)) to newborns from birth. The FDA has granted Priority Review for this application, with a Prescription Drug User Fee Act (PDUFA) action date set for August 25, 2026.

The European Medicines Agency (EMA) has also validated the marketing application for Tivicay, reflecting ViiV’s commitment to addressing critical gaps in care by expanding treatment options for the youngest patients. DTG, a second-generation integrase strand transfer inhibitor (INSTI), has a higher barrier to resistance than previous generations, making it a vital option for early intervention.

With untreated infants facing a high mortality rate from HIV, effective treatment from birth is crucial. Jean van Wyk, Chief Medical Officer at ViiV Healthcare, emphasized the importance of these submissions in ensuring that children are not left behind in HIV innovation. Supported by data from the IMPAACT 2023 study, these regulatory efforts aim to provide a safe and effective treatment for newborns, marking a significant step forward in pediatric HIV care.