US FDA approves ViiV Healthcare dispersible single tablet regimen containing dolutegravir, Triumeq PD to treat children living with HIV

US FDA approves ViiV Healthcare dispersible single tablet regimen containing dolutegravir, Triumeq PD to treat children living with HIV

By, Admin 1 April 2022

ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi B.V. (Shionogi) as shareholders, has announced that the US Food and Drug Administration (FDA) has approved a new drug application (NDA) for a dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1). In addition, a supplemental new drug application (sNDA) has been approved for Triumeq tablet, lowering the minimum weight that a child with human immunodeficiency virus type 1 (HIV-1) can be prescribed this medicine to 25kgs from 40kgs. According to UNAIDS, approximately 1.7 million children globally were living with HIV in 2020, with most AIDS-related deaths among this population occurring during the first five years of life. Therefore, the availability of age-appropriate treatment options is critical in ensuring young children can access optimal care. Deborah Waterhouse, CEO of ViiV Healthcare, said:

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