ViiV Healthcare submits FDA application for first dispersible single tablet regimen containing dolutegravir (DTG) for children living with HIV
ViiV Healthcare, the global specialist HIV company majority-owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, has announced it has made a regulatory submission to the U.S. Food and Drug Administration (FDA) for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir, dolutegravir and lamivudine and, to extend its current approval for Triumeq (abacavir/ dolutegravir/ lamivudine) to lower the minimum weight at which a child can be prescribed this medicine, from 40kg and above to 14kg and above. If approved, this approval will result in further treatment options for younger children living with HIV.
Paediatric HIV remains a global issue, with children disproportionately affected by the HIV epidemic. Latest statistics show there are 1.7 million children living with HIV globally, with most AIDS-related deaths among this group occurring during the first five years of life.
Major obstacles persist for children, such as the availability of HIV testing, continued vertical transmission, slow initiation of treatment and, poor availability of optimised paediatric formulations of antiretrovirals (ARVs)., The availability of age-appropriate treatment options is essential in ensuring children around the world can access optimal care.
Deborah Waterhouse, CEO of ViiV Healthcare, said: “UNAIDS reported that in 2020, 74% of adults living with HIV had access to treatment, compared to only 54% of children.1 This is a stark reminder of the gap between treatment options for adults and children and this submission represents another important step in ensuring that we address this disparity. By broadening the treatment options available to children living with HIV, we are one step closer to ending paediatric HIV and AIDS.”
This submission is based on modelled data and in line with regulatory guidance.
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