ViiV Healthcare has secured FDA Priority Review for its application to extend Tivicay PD to newborns from birth, alongside EMA validation of a parallel submission in Europe.

ViiV Healthcare has taken a step toward expanding HIV treatment options for newborns after the US Food and Drug Administration accepted a supplemental New Drug Application for Tivicay PD, granting Priority Review and setting a PDUFA date of 25 August 2026.

The application seeks to extend the use of dolutegravir-based regimens to infants from birth, a population historically described by the company as having “the fewest age-appropriate treatment options” in HIV care.

Jean van Wyk, chief medical officer at ViiV Healthcare, said the submissions represent an important step in addressing that gap, stating that “early HIV treatment can help shape a child’s future,” and adding that ViiV is committed to ensuring “children are not left behind in HIV innovation.”

The European Medicines Agency has also validated a marketing application for Tivicay, advancing parallel regulatory progress in Europe as the company seeks broader access across regions.

If approved, dolutegravir would become the first second-generation integrase strand transfer inhibitor available for use from birth, marking a potential expansion of modern antiretroviral therapy into the neonatal setting.

ViiV said newborns have historically had limited access to contemporary HIV regimens despite the rapid progression of disease in untreated infants, where around half may die by age two if left without treatment.

The regulatory submissions are supported by data from the IMPAACT 2023 study and pharmacokinetic modelling incorporating additional paediatric datasets, which demonstrated that dolutegravir achieved target exposure levels in term neonates with no new safety signals compared with older paediatric populations.

The company describes dolutegravir as a second-generation integrase strand transfer inhibitor with a higher barrier to resistance than earlier therapies, designed to inhibit HIV integrase and block viral DNA integration required for replication.

The application also builds on wider paediatric development efforts within ViiV Healthcare, including recent regulatory progress for dolutegravir-based combination therapies in younger age groups.

If approved, the expanded indication would extend access to one of the most widely used modern HIV drug classes into the earliest stages of life, addressing a long-standing gap in neonatal HIV treatment options.