ViiV gets EU approval for children’s HIV treatment
pharmafile | January 13, 2021 | News story | Research and Development | EU, HIV, ViiV
ViiV Healthcare, the global specialist HIV company, has received marketing authorisation from the European Commission for Tivicay (dolutegravir) 5mg dispersible tablets, which are used in combination with other antiretroviral agents for the treatment of HIV in children.
The drug has been granted approval for use in paediatric patients aged at least four weeks and weighing at least 3kg. The authorisation includes updated dosing recommendations for Tivicay film-coated tablets for children aged six or older and weighing at least 14kg, bringing these in line with the WHO’s weight bands.
The EU’s approval is based on data from the ongoing P10932 and ODYSSEY3 studies, which are being conducted in collaboration with international paediatric research networks, IMPAACT and PENTA-ID. This marketing authorisation follows the FDA’s approval of Tivicay PD in 2020, providing an age-appropriate formulation of dolutegravir for a younger population to help to close the gap between HIV treatment options available for adults and children.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “Today’s authorisation is a really important milestone towards enabling children to have access to age-appropriate formulations of HIV medicine.
“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.”
Darcy Jimenez
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