US-based Viatris has received tentative approval from the US Food and Drug Administration (FDA) for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension to treat HIV-1 infection in paediatric patients.

Abacavir/dolutegravir/lamivudine is a fixed-dose combination that consists of a pair of nucleoside reverse transcriptase inhibitors (NRTIs) and integrase strand transfer inhibitor (INSTI).

The strawberry-flavoured fixed-dose combination is intended to treat HIV-1 infection in children with a minimum weight of six kg.

The formulation has been given FDA provisional approval under the President’s Emergency Plan for AIDS Relief (PEPFAR) programme, which indicates that the combination meets all the agency’s standards for quality, safety, and efficacy.

The healthcare company has signed development agreements with ViiV Healthcare (ViiV) and the Clinton Health Access Initiative (CHAI) to produce and distribute the fixed-dose combination of abacavir, dolutegravir, and lamivudine.

Viatris also forged a licensing agreement for paediatric dolutegravir with the Medicines Patent Pool (MPP).

Viatris India, Emerging Asia & Access Markets president Rakesh Bamzai 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.”

As per the license agreement, the tentative clearance makes it easier to submit regulatory authority applications, and produce, and distribute the new child-friendly formulation across 123 low- and middle-income nations.

In March last year, abacavir/dolutegravir/lamivudine was approved in the US under the brand name Triumeq PD.