13 December 2019 - If approved, this new formulation of DTG will be the first integrase inhibitor available as a dispersible tablet for children living with HIV - closing the gap between treatment options available for adults and children.

VIIV, with Pfizer and Shionogi, today announced it has made regulatory submissions to both the EMA and the U.S. FDA seeking approval of the first-ever 5mg dispersible-tablet formulation of dolutegravir (DTG), as well as a simplified dosing regimen to optimise use of the existing DTG 50 mg film-coated tablet in paediatric HIV patients. The availability of age-appropriate formulations is essential in ensuring children around the world have access to optimal life-saving treatments.

These submissions to the EMA and FDA are based on data from the ongoing P1093 and ODYSSEY studies.

Read GSK press release