US FDA grants tentative approval for Viatris’ paediatric HIV drug

Global healthcare company Viatris Inc. on Tuesday said that it has received tentative approval from the US Food and Drug Administration (USFDA) for a New Drug Application. This approval paves the way for a medication, abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension, specifically designed to treat HIV-1 infection in paediatric patients.

The World Health Organization (WHO) recognises abacavir/dolutegravir/lamivudine as a preferred first-line regimen for paediatric patients. However, there has been a concerning gap in treatment coverage for children and adolescents living with HIV, with a significant portion not receiving the necessary antiretroviral therapy.

In 2022 alone, approximately 660,000 children, representing 43 percent of the estimated 1.5 million children living with HIV, did not have access to antiretroviral therapy. This treatment disparity led to children accounting for 13 percent of AIDS-related deaths in the same year, despite comprising only around 4 percent of the HIV-positive population.

The newly approved fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension offers hope to paediatric patients weighing at least 6 kg, the company said in a statement. These strawberry-flavoured tablets address a long-standing challenge in paediatric HIV treatment—providing medicine in forms that are both palatable and suitable for children, the company said.

This tentative FDA approval, facilitated through the President's Emergency Plan for AIDS Relief (PEPFAR) program, signifies that the medication formulation meets stringent standards for quality, safety, and efficacy. The development followed strategic partnerships, including a licensing agreement with the Medicines Patent Pool (MPP) and development collaborations with ViiV Healthcare (ViiV) and the Clinton Health Access Initiative (CHAI).

 “We have expanded access to high-quality HIV/AIDS treatment on a large scale for more than a decade. Over the years, we have continuously sought improvements to existing molecules to better meet patient needs. This includes introducing novel heat-stable generic formulations, offering more convenient packaging options, and developing paediatric therapies,” said Rakesh Bamzai, President of India, Emerging Asia & Access Markets at Viatris.

 “Additionally, we have forged strong partnerships with various stakeholders to enhance access to ARVs, with a particular focus on 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 significantly reduce the pill burden for children living with HIV,” he said.

This milestone aligns with Viatris’ sustainability goal of providing antiretroviral therapy 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 but less than 25 kg with HIV-1 infection. The prescribed dose is determined based on the patient's weight. It is important to note that this medication is contraindicated in patients with a prior hypersensitivity reaction to abacavir and in HLAB*5701-positive patients.

The tentative FDA approval will follow regulatory authority submissions and the production and distribution of this new child-friendly medication across 123 low- and middle-income countries, as per the licensing agreement.

This fixed-dose combination medication, abacavir/dolutegravir/lamivudine, represents an advancement in HIV treatment, combining nucleoside reverse transcriptase inhibitors (NRTIs) and an integrase strand transfer inhibitor (INSTI) to effectively combat the virus. Additionally, it emphasizes the importance of testing patients for hepatitis B virus (HBV) before initiating treatment, as co-infections have been associated with severe acute exacerbations of HBV. Abacavir/dolutegravir/lamivudine was approved in the US on 30 March 2022 under the brand name Triumeq PD.