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FDA Gives Tentative Clearance to Viatris’ HIV Treatment for Children


Company aims to improve access to WHO-recommended pediatric regimen for children with HIV in low- and middle-income countries.

HIV test label on HIV infection screening test form. Image Credit: Adobe Stock Images/gamjai

Image Credit: Adobe Stock Images/gamjai

Viatris broke news that the FDA has given its nod of a tentative approval for a new drug application. A formulation of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets, the medication will focus on the treatment of HIV in pediatric patients. A tentative approval means the formulation meets all the agency's quality, safety, and efficacy standards.

According to WHO, abacavir/dolutegravir/lamivudine should be used as a first-line treatment for pediatric patients with HIV. Due to children requiring specific medicine formulations, it has previously been challenging to treat HIV patients of this demographic.

"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,” said Rakesh Bamzai, president, India, emerging Asia and access markets, Viatris, in a company press release. “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."

Reference: Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment for Children Living with HIV. Viatris. September 5, 2023. Accessed September 6, 2023. https://newsroom.viatris.com/2023-09-05-Viatris-Announces-U-S-FDA-Tentative-Approval-of-a-Paediatric-Formulation-of-Abacavir-ABC-Dolutegravir-DTG-Lamivudine-3TC-,-a-Once-daily-Treatment-for-Children-Living-with-HIV

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