On November 12th, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending marketing authorisation for dolutegravir 5mg dispersible tablets for young children living with HIV. This decision was based, in part, on data from the ODYSSEY trial.
These small tablets can now be used in combination with other medicines for treating children living with HIV who are aged at least four weeks and weigh at least 3kg.
CHMP’s positive opinion also supported the updated dosing recommendations for dolutegravir film-coated tablets for children aged 6 years or older and weighing at least 14kg, including the use of an adult 50mg tablet in children weighing 20kg or more. The new dosing recommendations are now in line with the World Health Organization weight bands.
Both these decisions drew on evidence from a pharmocokinetics substudy of the ODYSSEY trial. In this sub-study, several blood samples were taken from children at different times after they had taken their medicines, and the level of dolutegravir in their blood was measured. This allowed researchers to see whether children taking different doses of dolutegravir had enough of the drug to keep their virus under control, and whether those doses were safe.
This opinion follows the US Food and Drug Administration (FDA) paediatric indication approval earlier this year. Together, these decisions help to expand the use of dolutegravir in children and close the gap between HIV treatment options available for adults and children.
We applaud CHMP’s statement as it represents a significant step forward in our commitment to improve treatment and speed up its availability to children living with HIV.
The main results of the ODYSSEY trial evaluating the safety and efficacy of dolutegravir in children weighing 14kg or more compared to standard treatment will be available in the first part of 2021. Results for children who weigh less than 14kg will be available in 2022.
The ODYSSEY trial is being carried out in hospitals in South Africa, Uganda, Zimbabwe, Thailand, USA, Argentina, Brazil, France, Portugal, Spain, UK and Germany. ODYSSEY is funded by ViiV Healthcare and the sponsor is the Penta Foundation.
- Lancet paper with pharmacokinetic results