FDA and EMA applications to expand dolutegravir indication to newborns from birth

23 June 2026. Related: Antiretrovirals, Paediatric care.

Simon Collins, HIV i-Base

On 22 June 2026, applications were submitted to both the US FDA and European Medicines Agency (EMA) to expand the indications for dolutegravir and a paediatric formulation of dolutegravir. [1]

If approved, this will provide an important new treatment option for newborn babies who currently have relatively much fewer treatment options, none of which include an integrase inhibitor.

Adult HIV treatment guidelines have recommended integrase inhibitors as initial ART for more than a decade – and now recommend using second generation INSTIs (dolutegravir or bictegravir).

However, the current indication for paediatric dolutegravir is for babies aged four weeks or older. The indication for bictegravir is for children aged two years and older.

The applications are supported by new age-specific dosing and clinical data, including from the IMPAACT 2023 study and the FDA has granted the application Priority Review.

Although the EMA submission is not being fast-tracked, it will support approval in low- and middle-income countries as well as in the EU.

The paediatric formulation of dolutegravir is marketed as Tivicay PD and dolutegravir is marketed as Tivicay.

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The latest update to the US paediatric guidelines already recommends using dolutegravir in newborn babies, in advance of any changes in the official indications. [2]

Reference

1. ViiV Press Release. ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay. (22 June 2026).
   https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2026/june/marketing-application-for-tivicay
2. Updated US paediatric HIV guidelines include dolutegravir from birth. HTB (1 July 2026).
   https://i-base.info/htb/54109