ViiV Healthcare has gained US approval for the first-ever dispersible tablet formulation of dolutegravir, Tivicay PD, a once-daily treatment for children living with HIV.
Dolutegravir is the first integrase inhibitor available as a dispersible tablet for oral suspension for children as young as four weeks of age and weighing at least 3kg.
Prior to this, dolutegravir was indicated in the US for children from six years of age and weighing more than 30kg.
This step will expand the use of dolutegravir by providing an age-appropriate formulation to a younger population and will help to close the gap between HIV treatment options available for adults and children.
The FDA approval is based on data from the ongoing P1093 and ODYSSEY (PENTA20) studies, which has been generated from ViiV Healthcare’s collaborations with the Division of AIDS (DAIDS) at the US National Institutes of Health (NIH) and the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) for P1093, and the Paediatric European Network for Treatment of AIDS (Penta) and the Medical Research Council (MRC) Clinical Trials Unit at University College London for ODYSSEY.
“I am delighted that our innovative approach to science has enabled us to achieve FDA approval of the first-ever dispersible tablet formulation of dolutegravir, now making it easier for young children to take this medication by dispersing the tablet in water,” said Deborah Waterhouse, CEO of ViiV Healthcare.
“The development and availability of age-appropriate formulations is essential in ensuring children have access to life-saving HIV treatments from an early age and as they grow. The support of our partners has been integral for this regulatory approval.
“We now need to continue our efforts to ensure this new dispersible formulation is available to children who need it around the world, in line with our mission to leave no person living with HIV behind.”