March 30, 2022: “ViiV Healthcare, the global specialist HIV company majority-owned by GlaxoSmithKline plc, with Pfizer Inc. and Shionogi B.V. as shareholders, has announced that the U.S. Food and Drug Administration has approved a NDA for 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 (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: “We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option.
Developing paediatric 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.”
Today’s FDA approval is an important step in fulfilling ViiV Healthcare’s commitment to bring optimised paediatric formulations containing dolutegravir to children.
In addition to today’s regulatory milestones, an application to approve the new dispersible tablet of the fixed dose combination of abacavir, dolutegravir and lamivudine for the treatment of paediatric patients with human immunodeficiency virus type 1 (HIV-1) and to extend the current approved Marketing Authorisation of Triumeq tablets to include a paediatric indication for children is currently under review by the European Medicines Agency (EMA).
Chip Lyons, President and CEO of the Elizabeth Glaser Paediatric AIDS Foundation (EGPAF), said: “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.
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.”
Through its paediatric voluntary licences, 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 optimised paediatric 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 (CHAI) and Unitaid in a public-private partnership.
About Triumeq
Two essential steps in the HIV life cycle are replication – when the virus turns its RNA copy into DNA – and integration – the moment when viral DNA becomes part of the host cell’s DNA.
These processes require two enzymes called reverse transcriptase and integrase. NRTIs and integrase inhibitors interfere with the action of the two enzymes to prevent the virus from replicating and further infecting cells.
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
Important Safety Information (ISI) for TRIUMEQ and TRIUMEQ PD (abacavir, dolutegravir, and lamivudine) tablets“
