5 May 2021
Geneva – A first generic version of the paediatric formulation of dolutegravir (DTG) as a 10 mg scored dispersible tablet is now ready to be supplied to low- and middle-income countries through the Medicines Patent Pool (MPP) generic manufacturing partner Viatris (through its subsidiary Mylan). Already more than ten countries have placed orders with the company, and the paediatric HIV medicine is starting to be delivered in Benin, Côte d’Ivoire, the Democratic Republic of the Congo, Haiti, Kenya, Malawi, Nigeria, Uganda, Zambia, Zimbabwe, as well as other sub-Saharan African countries through a pooled procurement mechanism.
1.8 million children around the world live with HIV, but in 2019 only 53% of them received antiretroviral therapy of which many were sub-optimal formulations[1]. In 2018, the World Health Organization (WHO) recommended DTG as part of preferred first- and second-line regimens for children. However, at that time, there was no adapted formulation for infants and young children. Thanks to the financial and technical support of international partners such as the partnership between Unitaid, the Clinton Health Access Initiative (CHAI) and ViiV Healthcare (the DTG patent holder), an access-oriented public health voluntary licence signed between ViiV Healthcare and MPP, and ViiV Healthcare agreeing to share technical knowledge to MPP sublicensees, by November 2020, Viatris had received U.S. Food and Drug Administration (U.S. FDA) tentative approval for their generic formulation of DTG 10 mg scored dispersible tablet. In March 2021, MPP generic manufacturing partner Macleods received U.S. FDA tentative approval too for the child-friendly formulation. Both formulations can be used for children as young as four weeks and weighing at least 3kg and the WHO-convened Paediatric ARV Working Group (PAWG) encourages transition to DTG-based regimens for all children on first- and second-line antiretroviral therapy, as outlined in the sixth edition of the Optimal Formulary and Limited-use List released last week[2]. Macleods is now ready to join forces and take orders too.
A pricing agreement negotiated by Unitaid and CHAI was announced in December 2020, making the WHO-recommended first-line and second-line paediatric HIV treatment available at an affordable price to the 121 countries covered by the ViiV Healthcare-MPP licence. MPP together with Global Accelerator for Paediatric Formulations (GAP-f) partners are actively collaborating to support rapid rollout and ensure that all children in need can have access to DTG.
Access the ViiV Healthcare-MPP licence on dolutegravir (paediatric)
Read more on MPP’s commitment to address children’s needs (including as a founding member of GAP-f)
Related Publications
[1] UNAIDS, Children living with HIV lagging behind adults in access to treatment, 8 March 2021
[2] WHO, 2021 optimal formulary and limited-use list for antiretroviral drugs for children, 26 April 2021
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.