FDA approval of a paediatric formulation of dolutegravir brings hope to infants and young children living with HIV around the world
25 November 2020
Geneva – The Medicines Patent Pool (MPP) congratulates our licensee Mylan (a subsidiary of Viatris Inc.) for the U.S. Food and Drug Administration (FDA) tentative approval of paediatric dolutegravir (DTG) 10 mg scored dispersible tablets. FDA’s positive decision on this much-needed formulation paves way for the World Health Organization (WHO)-recommended treatment to reach infants (at least 4 weeks old and weighing at least 3 kg) living with HIV in low- and middle-income countries. According to WHO, half of the infants living with HIV will die before their second birthday without prompt diagnosis and treatment.
“Young children have been long left behind in the fight against HIV. They deserve better. This excellent news on the adapted formulation promises a future to infants living with HIV,” said MPP’s Executive Director Charles Gore. “MPP will continue to work hard with partners including CHAI, Viatris Inc., ViiV Healthcare and Unitaid to ensure these affordable child-friendly formulations reach those in need.”
Paediatric versions of DTG are included in MPP’s existing licence with ViiV Healthcare that covers 99% of children living with HIV.
Paediatric versions of DTG