Paediatric dolutegravir/lamivudine submitted to EMA and FDA for use in younger children

Simon Collins, HIV i-Base

On 11 May 2026, ViiV Healthcare announced that it had submitted applications to the European Medicines Agency (EMA) and the US FDA to extend the indications for dolutegravir/lamivudine (DTG/3TC) to younger children.

The applications include a new dispersible tablet formulation for children aged ≥3 months and weighing 6 kg to 25 kg. They also include an extension of the film-coated tablet indication to paediatric patients weighing at least 20 kg.

The current indications are for children who are at least 12 years old and who weigh at least 40 kg in the EU, and weighing at least 25 kg in the US.

Dolutegravir/lamivudine is manufactured and marketed by ViiV Healthcare under the trade name Dovato.

Reference

ViiV press release. ViiV Healthcare aims to close treatment gaps for children living with HIV with paediatric Dovato marketing applications to the EMA and FDA. (11 May 2026).
https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/may/aims-to-close-treatment-gaps-for-children-living-with-hiv/