Viatris Inc. Announces FDA Tentative Approval of a Pediatric Formulation of Dolutegravir (DTG) Under PEPFAR

IndustryPRwire -- Viatris Inc announced tentative approval from the U.S. Food and Drug Administration (FDA) for a New Drug Application for pediatric dolutegravir tablets for oral suspension, 10 mg. The new formulation is a result of a collaboration with ViiV Healthcare, the Clinton Health Access Initiative and Unitaid to help expand access to children living with HIV/AIDS in low- and middle-income countries. Tentative approval was granted under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) which permits products that are not approved for marketing in the U.S. because of patent protection or other marketing restrictions to be distributed in other countries where they are critically needed.

Pediatric dolutegravir tablets were approved for use in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in pediatric patients at least 4 weeks old and weighing at least 3 kg. The World Health Organization (WHO) recommends this product as part of a preferred first-line treatment regimen for children who meet the criteria. According to the organization, half of HIV-positive infants will die before their second birthday without prompt diagnosis and treatment.

Viatris President Rajiv Malik said, "The FDA's decision clears the way for Viatris to deliver this urgently needed treatment to some of the world's most vulnerable children living in regions that are home to 99% of children living with HIV. Pediatric dolutegravir tablets are a significant new addition to a product portfolio that has made Viatris the world's largest supplier of ARVs. We have a deep commitment to increasing access to more affordable treatments and will continue to find innovative solutions to reach those in need."

Dolutegravir tablets for oral suspension should not be co-administered with dofetilide; it may cause hypersensitivity reactions; hepatotoxicity has been reported in patients receiving dolutegravir-containing regiments and embryo-fetal toxicity may occur when used at the time of conception and in early pregnancy.

Viatris, launched last week through the combination of Mylan N.V. and Pfizer's Upjohn business, provides approximately 40% of those on treatment for HIV/AIDS with a Viatris product, including approximately 60% of the world's HIV-positive children on treatment.

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