ViiV Healthcare has bagged a marketing authorisation for a dispersible tablet formulation of its HIV-1 treatment Tivicay (dolutegravir) in paediatric patients aged at least four weeks and weighing at least 3kg.
The EU authorisation makes Tivicay the first integrase inhibitor available as a dispersible tablet for children in this population, ViiV commented in a statement.
The approval is based on data from the ongoing P1093 and ODYSSEY studies – both studies are being conducted in collaboration with international paediatric research networks, IMPACT and PENTA-ID.
“Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine,” said Deborah Waterhouse, chief executive officer of ViiV Healthcare.
“Globally there are approximately 1.7 million children living with HIV and around 100,000 children dying each year from AIDS which is why we won’t stop doing all that we can to ensure that no child living with HIV is left behind,” she added.
In 2020, the US Food and Drug Administration (FDA) also approved the dispersible tablet formulation of Tivicay for the treatment of HIV-1 infection in the same paediatric population.
At the same time, the FDA also approved an extended indication to expand the use of already-approved Tivicay 50mg film-coated tablet in paediatric HIV patients weighing 20kg and above.