London, – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today 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 and assigned a Prescription Drug User Fee Act (PDUFA) action date of August 25, 2026.

The European Medicines Agency (EMA) has also validated the marketing application for Tivicay, as the company continues to focus on addressing one of the most persistent gaps in care by expanding age-appropriate treatment options for the earliest stage of life.

DTG is a second-generation integrase strand transfer inhibitor (INSTI) with a higher barrier of resistance than previous generations. Without early diagnosis and treatment, HIV can progress rapidly in infants, with around 50% of untreated infants living with HIV dying by age two, underscoring the importance of effective treatment options from birth.

Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Early HIV treatment can help shape a child’s future, yet newborns have historically had the fewest age-appropriate treatment options. ViiV Healthcare has a long-standing commitment to changing that and helping ensure children are not left behind in HIV innovation. These regulatory submissions are a key step toward bringing an innovative, INSTI-based treatment to newborns from birth.”

The submissions to the FDA and the EMA are supported by data from the IMPAACT 2023 study and pharmacokinetic (PK) modelling incorporating additional paediatric data, demonstrating that DTG achieved target PK exposures in term neonates with no new safety findings observed, compared with older paediatric populations.

These submissions build on recent announcements for dolutegravir/lamivudine (DTG/3TC) that the EMA had validated the marketing application seeking approval to extend use to younger age groups, alongside submission of a New Drug Application to the FDA.

About Tivicay and Tivicay PD

Tivicay and Tivicay PD contain dolutegravir, an integrase strand transfer inhibitor for use in combination with other antiretroviral agents for the treatment of HIV. Integrase inhibitors inhibit HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

Please consult the full Prescribing Information here.

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

About IMPAACT

The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network is a global collaboration of investigators, institutions, community representatives, and other partners with a mission to improve health outcomes in infancy, childhood, adolescence, pregnancy, and postpartum among those who are impacted by or living with HIV, tuberculosis, and other related complications through the conduct of high-quality clinical trials. IMPAACT’s vision and overall goal is to end the worldwide HIV epidemic among these populations. To achieve this goal, the IMPAACT Network evaluates novel and durable treatments for HIV, TB, and related diseases and conditions, strategies for antiretroviral treatment (ART)-free remission, and strategies to prevent and manage neuropsychological and mental health complications of HIV and its treatment. Overall support and funding for IMPAACT is provided by the National Institute of Allergy and Infectious Diseases (NIAID), with support and co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH), all components of the United States National Institutes of Health (NIH). The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. For more information, please visit: www.impaactnetwork.org.

About the National Institutes of Health (NIH)

NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit: www.nih.gov.

About ViiV Healthcare

ViiV Healthcare is a global specialist HIV company established in November 2009 with GSK (LSE: GSK) and Shionogi as current shareholders. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. ViiV Healthcare’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

About GSK  

GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.