Viatris (NASDAQ:VTRS) shares are ticking higher today after the healthcare company announced a tentative approval from the U.S. Food and Drug Administration (FDA). The approval is for a new drug application for a formulation of abacavir/dolutegravir/lamivudine tablets as a once-daily treatment for HIV-1 infection in children.
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Importantly, the World Health Organization (WHO) recommends this formulation as a preferred first-line regimen for children. The tentative approval from the FDA comes through the President’s Emergency Plan for AIDS relief program.
According to the company, in 2022, 43% of the approximately 1.5 million children affected by HIV did not receive antiretroviral therapy, highlighting the inadequate treatment coverage for children and adolescents compared to adults. Despite children representing only 4% of the HIV-affected population, pediatric deaths accounted for 13% of total AIDS-associated deaths last year.
Significantly, this tentative approval will facilitate regulatory submissions, production, and distribution of the fixed-dose combination across 123 low and middle-income countries.
Overall, the Street has a consensus price target of $12.25 on Viatris, along with a Hold consensus rating. Shares of the company have gained nearly 13% over the past year.
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