Business
Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV
Tentative approval will help enhance access to WHO-recommended paediatric regimen with the goal of improved adherence of HIV treatment for children in low-
About this update from Viatris Inc.
[{"type":"text","content":"Tentative approval will help enhance access to WHO-recommended paediatric regimen with the goal of improved adherence of HIV treatment for children in low- and middle-income countries\nPITTSBURGH and BANGALORE, India, Sept. 5, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, today announced U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients.\nThe World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), treatment coverage for children and adolescents lags behind adults. Some 660,000 children living with HIV – about 43 percent of the estimated total 1.5 million [1.2 million–2.1 million] children living with HIV – did not receive antiretroviral (ARV) therapy in 2022. Accordingly, children accounted for 13 per cent of AIDS-related deaths in 2022, even though they comprise only about 4 percent of people living with HIV.\nThe fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg. The fixed-dose combination tablets for oral suspension are strawberry-flavoured. Historically, it has been challenging to treat paediatric HIV patients because children require special medicine formulations.\nThe FDA's tentative approval through the President's Emergency Plan for AIDS Relief (PEPFAR) program means the formulation meets all the agency's quality, safety, and efficacy standards. Viatris has signed a licensing agreement for paediatric dolutegravir from the Medicines Patent Pool (MPP) and development agreement with ViiV Healthcare (ViiV) and the Clinton Health Access Initiative (CHAI) for producing and distributing the fixed-dose combination of abacavir/ dolutegravir/lamivudine.\nRakesh Bamzai, President of India, Emerging Asia & Access Markets at Viatris, said, \"At Viatris, we have expanded access at scale to high-quality HIV/AIDS treatment for more than a decade. Over the years, we have continued to seek improvements to existing molecules to better meet...