FDA grants tentative approval for Viatris’s new drug application to treat HIV-1 infection in paediatric patients, ET HealthWorld


Pittsburgh: Viatris Inc announced the 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 six 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) programme 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, India, Emerging Asia & Access Markets, Viatris, said, “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 two 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.

  • Published On Sep 5, 2023 at 04:34 PM IST

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