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
Press and Media
The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries. Through its innovative business model, MPP partners with civil society, governments, international organisations, industry, patient groups, and other stakeholders to prioritise and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations.
To date, MPP has signed agreements with 22 patent holders for 13 HIV antiretrovirals, one HIV technology platform, three hepatitis C direct-acting antivirals, a tuberculosis treatment, a cancer treatment, four long-acting technologies, a post-partum haemorrhage medicine, three oral antiviral treatments for COVID-19 and 16 COVID-19 technologies.
MPP was founded by Unitaid, which continues to be MPP’s main funder. MPP’s work on access to essential medicines is also funded by the Swiss Agency for Development and Cooperation (SDC), Government of Canada, the World Intellectual Property Organization (WIPO) and the Government of Flanders. MPP’s activities in COVID-19 are undertaken with the financial support of the Japanese Government, the French Ministry for Europe and Foreign Affairs, the German Agency for International Cooperation, and SDC.