ViiV Healthcare receives EU Marketing Authorisation for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV in Europe
pharmafile | February 22, 2023 | News story | Business Services |
London, 22 February 2023 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced the European Commission has granted Marketing Authorisation for Triumeq PD, a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients weighing 14 kg to <25 kg with human immunodeficiency virus type 1 (HIV-1). This authorisation includes the label extension of Triumeq tablet, lowering the minimum weight that a child with HIV-1 can be prescribed this medicine from 40 kg to 25 kg.
Despite significant advances in HIV treatment and care, only 52% of children living with HIV (under 14 years old) had access to optimised paediatric formulations of antiretrovirals in 2021.[i] The EU Marketing Authorisation follows the US Food and Drug Administration (FDA) approval of Triumeq PD in 2022. This provides access to age-appropriate formulations of dolutegravir for a younger population and helps to close the gap between HIV treatment options available for adults and children living with HIV.
Deborah Waterhouse, CEO at ViiV Healthcare, said: “Today, we are delighted to have received the EU Marketing Authorisation for Triumeq PD, expanding the options for child-friendly HIV treatments available in Europe. At ViiV Healthcare, we are committed to pushing the boundaries to develop medicines that address the unmet needs of the estimated 1.7 million children living with HIV, bringing us closer to achieving our mission of ensuring no one living with HIV – regardless of their age – is left behind.”
Amanda Ely, CEO at Chiva said: “Currently, young children face significant challenges due to limited age-appropriate treatment and therefore fewer children are achieving viral suppression, compared to adults.1 Through improved treatment options, increased access, and community support, we can increase the number of children living with HIV achieving viral suppression. Furthermore, by successfully initiating young children onto age-appropriate treatments, it can help them foster a positive relationship with their lifelong treatment regimen early on.”
[i] UNAIDS. Global HIV & AIDS Statistics – 2022 Fact Sheet. Available at: https://www.unaids.org/sites/default/files/media_asset/UNAIDS_FactSheet_en.pdf. Accessed February 2023.
