Tentative approval will help enhance access to WHO-recommended paediatric regimen with the goal of improved adherence to HIV treatment for children in low- and middle-income countries

Viatris announced US 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 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 a 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.”

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.