The approval allows the dispersible tablet formulation of dolutegravir, in combination with other antiretroviral treatments, to be used in treatment-naïve paediatric patients aged more than four weeks and weighing more than 3kg.
The FDA has also extended the use of the already approved 50mg film-coated dolutegravir tablet in paediatric HIV patients weighing 20kg and above.
Dolutegravir, which is now the first integrase inhibitor that can be used as a dispersible tablet for oral suspension for pediatric patients, was approved previously in the US for children from six years of age with a weight of more than 30kg.
According to ViiV Healthcare, integrase inhibitors prevent HIV integrase by binding to the integrase active site and preventing the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is necessary for the HIV replication cycle.
FDA Center for Drug Evaluation and Research Division of Antivirals director Debra Birnkrant said: “For babies and young children with HIV, getting treatment early is very important. HIV can progress more quickly in children than adults.
“While the incidence of pediatric HIV infections continues to decline, the availability and early initiation of effective treatment are critical for infants and children living with HIV. Tivicay and Tivicay PD are taken once daily, which could help patients and caregivers better adhere to the regimen.”
The safety and effectiveness of the two formulations of the drug were backed by a trial that featured 75 HIV-1–infected infants, children, and adolescents, aged four weeks to less than 18 years old.
ViiV Healthcare CEO Deborah Waterhouse said: “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.”