Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation ofAbacavir

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

PITTSBURGH and BANGALORE, India, Sept. 5, 2023 – 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.

The 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.

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 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.

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 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.

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 paediatric 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 paediatric 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.

About the fixed-dose combination of abacavir/dolutegravir/lamivudine tablets for oral suspension

Abacavir/dolutegravir/lamivudine is a fixed-dose combination containing two nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI). NRTIs interfere with the action of the reverse transcriptase enzyme and INSTI interferes with the action of integrase enzyme to prevent the virus from replicating.  All patients with HIV-1 should be tested for the presence of hepatitis B virus (HBV) prior to or when initiating the fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg as severe acute exacerbations of HBV have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued the medication.

Abacavir/dolutegravir/lamivudine was approved in the US on 30 March 2022 under the brand name Triumeq PD.

Triumeq PD is registered trademark of the ViiV Healthcare group of companies.