Triumeq PD is a fixed-dose combination antiretroviral medication containing abacavir, dolutegravir and lamivudine, formulated as a dispersible tablet
Triumeq PD is a fixed dose antiretroviral medication. (Credit: Ajale from Pixabay.)
ViiV Healthcare, a GSK company specialising in HIV treatment, has received the US Food and Drug Administration (FDA) approval for Triumeq PD to treat children living with HIV-1.
Triumeq PD is a fixed-dose combination antiretroviral medication containing abacavir, dolutegravir and lamivudine, formulated as a dispersible tablet.
Abacavir is a reverse transcriptase inhibitor, dolutegravir is an integrase inhibitor and lamivudine is a nucleoside analogue reverse transcriptase inhibitor.
The three medications work with distinct and complementary mechanisms of action to prevent the replication of HIV.
The US agency has approved the company’s new drug application (NDA) for Triumeq PD for the treatment of HIV-1 in paediatric patients weighing between 10kg and 25kg.
In addition, the US FDA has approved a supplemental new drug application (sNDA) for Triumeq, lowering the weight limit to 25kg from the previous 40kg.
ViiV Healthcare CEO Deborah Waterhouse said: “We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option.
“Developing paediatric formulations of antiretroviral treatments is a priority for ViiV Healthcare because we want to ensure that no one living with HIV is left behind and this approval means that we are one step closer to closing the gap between HIV treatment options available for adults and children.”
With the FDA approval, Triumeq PD can now be provided with an optimised paediatric formulation containing dolutegravir as a treatment option for children with HIV.
ViiV Healthcare has submitted an application to the European Medicines Agency (EMA), seeking expanded approval for Triumeq to include a paediatric indication.
The drug was previously authorised for the treatment of HIV-1 in adults and adolescents, aged 12 years and older, who weigh at least 40kg.
ViiV Healthcare said that through its paediatric voluntary licences, will promote the manufacturing and royalty-free sale of dolutegravir generic versions.
The move will support the treatment of children living with HIV in developing, low-income, lower-middle-income and sub-Saharan African countries, along with a few upper-middle-income countries.
Furthermore, the company is working with the Clinton Health Access Initiative (CHAI) and Unitaid in a public-private partnership.
The current approval closely follows the recent FDA approval expanding the indication for Cabenuva, to include virologically suppressed adolescents, aged 12 years and above.