ViiV Healthcare press release
London, 11 May 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced that the European Medicines Agency (EMA) has validated the company’s marketing application seeking approval to extend the use of Dovato (dolutegravir/lamivudine (DTG/3TC)) to younger age groups. A New Drug Application was also submitted to the U.S. Food and Drug Administration (FDA) as part of ViiV Healthcare’s commitment to help address longstanding gaps in HIV treatment options for children living with HIV.
An estimated 620,000 of the 1.4 million children living with HIV were not receiving antiretroviral therapy (ART) in 2024. Paediatric treatment options remain limited, and younger children lack child-friendly formulations, underscoring the need for age-appropriate options.
The applications include a new dispersible tablet formulation for children aged ≥3 months and weighing ≥6 kg to <25kg and an extension of the film-coated tablet indication to paediatric patients weighing at least 20 kg. If approved, this 2-drug regimen could help reduce cumulative drug exposure for children who face decades of continuous ART.
Read the full press release here.
Source : ViiV Healthcare
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