FDA grants tentative approval for ViatrisViatris’ HIV therapy for children

06 Sep 2023
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FDA grants tentative approval for Viatris’ HIV therapy for children
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Source: Pharmaceutical Technology
The once-daily tablet is indicated for use in children weighing a minimum of 6kg to less than 25kg. Credit: Beenicebeelove/ Shutterstock.com.
The US Food and Drug Administration (FDA) has granted tentative approval for Viatris’ new drug application of a single-tablet regimen to treat HIV-1 infection in the paediatric population.
The once-a-day tablet for oral suspension comprises a fixed-dose combination of 60mg abacavir, 5mg dolutegravir and 30mg lamivudine.
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Viatris noted that the therapy is indicated for use in children weighing a minimum of 6kg to less than 25kg and has a strawberry flavour.
The recommended dose of the treatment is weight proportionate and is not intended for usage in patients with a previous hypersensitivity reaction to abacavir as well as in individuals who are HLAB*5701-positive.
This tentative approval will aid in making submissions to regulatory authorities, manufacturing and supply of the new paediatric formulation in 123 low and middle-income countries.
Viatris has a licensing agreement in place with the Medicines Patent Pool for paediatric dolutegravir.
To manufacture and supply HIV treatment, the company signed a development deal with ViiV Healthcare and the Clinton Health Access Initiative.
The combination treatment is currently recommended by the World Health Organization as a first-line treatment for paediatric HIV patients.
Viatris Emerging Asia and Access Markets India president Rakesh Bamzai said: “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.
“The approval of this single-tablet regimen – the fixed-dose combination of abacavir 60mg/dolutegravir 5mg/lamivudine 30mg – will reduce the pill burden for children living with HIV.”
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