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:
