FDA accepts sNDA and EMA validates Tivicay PD (dolutegravir) for newborns with HIV, with Priority Review and an August 25, 2026 PDUFA date
Written By: Sana Khan, BPharm
Reviewed By: Pharmacally Editorial Team
ViiV Healthcare has moved closer to expanding HIV treatment options for the youngest patients after the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for Tivicay PD (dolutegravir) to treat newborns from birth. The agency granted Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 25, 2026.
The company also reported that the European Medicines Agency (EMA) has validated its marketing application for the same indication, advancing regulatory reviews on both sides of the Atlantic.
If approved, Tivicay PD could become one of the first integrase strand transfer inhibitor (INSTI)-based treatment options available for term neonates living with HIV, addressing a longstanding gap in pediatric HIV care.
Critical Gap in Neonatal HIV Care
Despite significant advances in HIV treatment, therapeutic options for newborns remain limited. Early diagnosis and rapid treatment initiation are particularly important in this population because HIV progresses more aggressively in infants than in older children or adults. Without treatment, approximately half of infants living with HIV die before reaching two years of age.
Dolutegravir is a second-generation INSTI that blocks HIV integrase, an enzyme essential for viral replication. Compared with earlier-generation agents, dolutegravir offers a higher barrier to resistance and has become a cornerstone of HIV treatment across multiple age groups.
Expanding its use to newborns could provide clinicians with an effective and age-appropriate treatment option immediately after birth.
Data Supporting the Regulatory Filings
The FDA and EMA submissions are supported by findings from the IMPAACT 2023 study (NCT05406583) along with pharmacokinetic (PK) modeling that incorporated additional pediatric data.
The analyses showed that dolutegravir achieved target drug exposure levels in term neonates while maintaining a safety profile consistent with that observed in older pediatric populations. Investigators reported no new safety signals during the evaluation.
The development program focused on confirming appropriate dosing and drug exposure in newborns, a key requirement for regulatory approval in this age group.
Advancing Pediatric HIV Treatment
Jean van Wyk, Chief Medical Officer at ViiV Healthcare, emphasized the need for earlier access to modern HIV therapies for children. He noted that newborns have historically had the fewest age-appropriate treatment options despite the importance of immediate treatment after diagnosis.
The latest submissions reflect the company’s broader effort to expand access to dolutegravir-based therapies across younger pediatric populations. They follow recent regulatory filings for dolutegravir/lamivudine (DTG/3TC), which are also under review for use in younger children.
Regulatory Review Progress
The FDA is expected to complete its review by August 25, 2026. A positive decision would expand the Tivicay PD label to include newborns from birth, potentially providing clinicians with a new INSTI-based treatment option during the earliest stage of life.
Meanwhile, EMA review of the application is underway. Regulatory approvals in both regions could help improve access to modern HIV treatment for newborns globally and support earlier intervention in one of the most vulnerable patient populations.
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About the Writer
Sana Jamil Khan (LinkedIn) is a B. Pharm graduate with a strong interest in medical writing and scientific communication. Her work focuses on interpreting clinical research, exploring developments in pharmaceutical science, and presenting complex medical information in a clear and accessible manner. She is particularly interested in topics related to human clinical studies, drug safety observations, and emerging therapeutic research.