Viatris Inc., a global healthcare company with a center in India, on 5 September announced the US Food and Drug Administration’s (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 pediatric patients.
The World Health Organization (WHO) recommends abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients. According to the Joint United Nations Program on HIV/AIDS (UNAIDS), the treatment coverage for children and adolescents lags behind adults.
Some 660,000 children living with HIV – about 43%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% of AIDS-related deaths in 2022, even though they comprise only about 4 percent of people living with HIV.
The 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 weighing at least 6 kg. The fixed-dose combination tablets for oral suspension are strawberry-flavoured. Historically, it has been challenging to treat pediatric HIV patients because children require special medicine formulations.
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. 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 abacavir/ dolutegravir/lamivudine.
Rakesh 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 patient needs – we have introduced novel heat-stable generic formulations, more convenient packaging options, and pediatric therapies. We have also built strong partnerships with multiple stakeholders to improve access to ARVs, with particular attention to vulnerable populations like children. The approval of this single tablet regimen – the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg – will reduce the pill burden for children living with HIV.”
This milestone supports the company’s sustainability goal to provide ARV therapy equivalent to a total of 30 million patients, including more than 2 million children living with HIV/AIDS, between 2022 and the end of 2025.
The fixed-dose combination of abacavir/dolutegravir/lamivudine is approved for once-daily treatment of pediatric patients weighing at least 6 kg to <25 kg with HIV-1 infection and the recommended dose of the fixed-dose combination of abacavir/dolutegravir/lamivudine tablets for oral suspension is determined according to weight. The fixed-dose combination of abacavir/dolutegravir/lamivudine are contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLAB*5701-positive patients. 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.
Viatris provides access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through its Global Healthcare Gateway. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories.
Viatris is headquartered in the US, with global centers in Pittsburgh, Shanghai and Hyderabad, India.