ViiV Healthcare receives FDA green light for Triumeq
ViiV Healthcare, a global specialist HIV company majority-owned by GlaxoSmithKline, with Pfizer and Shionogi as shareholders, has obtained the Food and Drug Administration’s permission for Triumeq.
Triumeq is a dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir and lamivudine for the treatment of pediatric patients weighing 10kgs to <25 kgs with human immunodeficiency virus type 1 (HIV-1).
In addition, a supplemental new drug application has been approved for the 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.
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The first dispersible single-tablet regimen containing dolutegravir increases age-appropriate treatment options for children living with HIV, the company said.
“We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option,” said Deborah Waterhouse, CEO of ViiV Healthcare. “Developing pediatric formulations of anti-retroviral 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.”
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, the company noted.
“Children are still disproportionality impacted by the HIV epidemic with only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need and even fewer still reaching viral suppression,” said Chip Lyons, president and CEO of the Elizabeth Glaser Paediatric AIDS Foundation. “An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste and this presents a real challenge to many caregivers’ ability to administer life-saving medicine. Today’s approval of a child-friendly formulation of a single tablet regimen will help meet the urgent needs of this vulnerable population.”
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Through its pediatric voluntary licenses, ViiV Healthcare enables generic versions of dolutegravir to be manufactured and sold royalty-free for the treatment of children living with HIV in all least-developed, low-income, lower-middle-income and sub-Saharan Africa countries, as well as some upper-middle-income countries.
In order to ensure licensees expedite the development and introduction of optimized pediatric formulations containing dolutegravir to help the children most affected by HIV, the majority of whom reside in sub-Saharan Africa, ViiV Healthcare works with the Clinton Health Access Initiative and Unitaid in a public-private partnership.