Viatris gets US FDA's tentative approval for pediatric formulation of HIV medicine

The World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients.

US–based pharma company Viatris Inc. on September 5 announced the US Food and Drug Administration (FDA) tentative approval for a New Drug Application for the treatment of HIV-1 infection in pediatric patients.

The medicine is a 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 pediatric patients aged at least 3 months weighing at least 6 kg to less than 25 kgs.

The World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for pediatric patients.

The approval of this single tablet regimen will reduce the pill burden for children living with HIV, Rakesh Bamzai, President of India, Emerging Asia & Access Markets at Viatris said in a press statement.

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. Additionally, 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.

The 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, the company said.

Viatris has signed a licensing agreement for pediatric 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 the drugs. The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries.

The tentative approval facilitates regulatory authority submissions, production and distribution of the new child friendly formulation across 123 low-and middle-income countries as per the license agreement.

The fixed-dose combination tablets for oral suspension are strawberry-flavoured.