ViiV Healthcare has received approval from the US Food and Drug Administration (FDA) for Tivicay PD (dolutegravir) tablets, in combination with other antiretroviral agents, to treat children with human immunodeficiency virus type 1 (HIV-1) infection.
The drug is indicated for patients aged at least four weeks and weighing at least 3kg.
Furthermore, the FDA expanded the use of Tivicay 50mg film-coated tablet for the treatment of HIV in paediatric patients weighing 20kg and above.
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.
“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.”
Dolutegravir is an integrase strand transfer inhibitor previously indicated to treat children aged six years and above, weighing more than 30kg in the US.
The latest FDA approval is based on results from the ongoing P1093 and ODYSSEY (PENTA20) clinical trials, which involve paediatric patients aged four weeks to 18 years.
P1093 is being performed by the IMPAACT network in the US, Brazil, Thailand, South Africa, Zimbabwe, Kenya and Tanzania, while PENTA network is performing ODYSSEY in Europe, South America, Thailand, Uganda, Zimbabwe and South Africa.
Under a voluntary licensing policy, ViiV Healthcare allows the manufacture of generic versions of dolutegravir to be sold royalty-free in least-developed, low-income, lower-middle-income and sub-Saharan Africa and certain upper-middle-income countries.
In March, ViiV Healthcare and Janssen Pharmaceutical secured the Health Canada approval of Cabenuva as a once-monthly, long-acting therapy for adults with HIV-1 infection.
Cabenuva comprises ViiV Healthcare’s cabotegravir and Janssen’s rilpivirine. ViiV Healthcare holds the drug’s marketing rights in Canada.