FDA Grants Priority Review for Dolutegravir in Newborns With HIV

According to a new announcement from ViiV Healthcare, the FDA has accepted a supplemental New Drug Application (sNDA) for dolutegravir (Tivicay PD, ViiV Healthcare) to extend its use to newborns from birth, granting Priority Review with a PDUFA action date of August 25, 2026.¹ The European Medicines Agency (EMA) simultaneously validated a separate marketing application for dolutegravir (Tivicay, ViiV Healthcare) in the same neonatal population.¹

The regulatory milestones mark a significant step in closing one of the most persistent gaps in HIV treatment: access to modern antiretroviral therapy for the youngest patients. Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) with a higher barrier to resistance than previous-generation agents; if approved, it would be the first second-generation INSTI available for newborns.

IMPAACT 2023 PK Data

The sNDA and EMA marketing application are supported by data from the IMPAACT 2023 study, conducted within the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, alongside pharmacokinetic (PK) modeling incorporating additional pediatric data.¹ Findings demonstrated dolutegravir achieved target PK exposures in term neonates, with no new safety signals identified compared with older pediatric populations.¹ The IMPAACT Network, supported by the National Institute of Allergy and Infectious Diseases (NIAID) with co-funding from NICHD and NIMH, focuses specifically on improving HIV outcomes from birth through adolescence.

The urgency of early treatment is underscored by available epidemiologic data: approximately 50% of untreated infants living with HIV die by age two, according to UNICEF and UNAIDS.² Newborns have historically faced the fewest age-appropriate HIV treatment options, with access to modern INSTI-based regimens limited or absent in this population. Current antiretroviral options for the neonatal period rely largely on older-generation agents with lower resistance barriers and less favorable tolerability profiles.

These submissions build on ViiV Healthcare's broader pediatric pipeline expansion. In May 2026, the company announced the EMA had validated a marketing application for dolutegravir/lamivudine (DTG/3TC) to extend use to younger age groups, alongside an FDA NDA submission for the same regimen. Age-appropriate formulation development, including the dispersible tablet formulation of Tivicay PD, has been central to expanding INSTI access across pediatric subpopulations.

"Early HIV treatment can help shape a child's future, yet newborns have historically had the fewest age-appropriate treatment options," ViiV Healthcare Chief Medical Officer Jean van Wyk, MBChB, MFPM, said in a statement.

If the FDA approves the sNDA by the PDUFA date, dolutegravir would join a narrow field of antiretrovirals indicated from birth, potentially reshaping neonatal HIV treatment guidelines and expanding access to second-generation INSTI therapy at the earliest stage of life.

Frequently Asked Questions

What is dolutegravir (Tivicay PD) approved for?

Dolutegravir is approved for use in combination with other antiretroviral agents for HIV treatment across multiple age groups; the current sNDA seeks to extend that use to newborns from birth.

How does dolutegravir work?

Dolutegravir is a second-generation integrase strand transfer inhibitor (INSTI) — it blocks the strand transfer step of HIV DNA integration into host cells, a process essential to viral replication, with a higher barrier to resistance than first-generation INSTIs.

What did the IMPAACT 2023 study show?

The IMPAACT 2023 study, combined with PK modeling from additional pediatric data, demonstrated dolutegravir achieved target PK exposures in term neonates with no new safety signals compared with older pediatric populations.

References

1. ViiV Healthcare. ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay. Press release. June 22, 2026.

2. UNICEF and UNAIDS. The Cost of Inaction: Children and Adolescents Living with HIV in Eastern and Southern Africa. Published 2023. Accessed June 2026.