Three Neglected-Disease Treatments Added to WHO Essential Medicines List for Pediatric Use

This week the World Health Organization (WHO) released its newly updated 4th WHO Model List of Essential Medicines for Children (EMLc), in which three treatments developed by the Drugs for Neglected Diseases initiative (DNDi) and its partners have now been included. One treatment was also added to the 18th WHO Model List of Essential Medicines (EML) for adults.

Artesunate-mefloquine fixed-dose combination (ASMQ FDC) was added to the EMLc for the treatment of malaria in children, and to the EML for adults, in line with current WHO treatment guidelines. ASMQ FDC was developed with Farmanguinhos/Fiocruz (Brazil) and launched first in Brazil in 2008. After a technology transfer to Cipla (India), ASMQ FDC was prequalified by WHO in 2012, and registered in India, Malaysia, and Myanmar in 2011-2013.

Nifurtimox-eflornithine combination therapy (NECT) was added to the EMLc for the treatment of late-stage sleeping sickness (human African trypanosomiasis) in children. Developed in partnership with Médecins Sans Frontières, Epicentre, and the Swiss Tropical and Public Health Institute, NECT was launched and added to the EML for adult treatment in 2009. NECT is the first new treatment option in over 25 years for sleeping sickness. It has been implemented and distributed by WHO - supported by donations by Sanofi and Bayer - through national control programs in the 12 sub-Saharan African countries where 98 percent of late-stage sleeping sickness cases occur, replacing an old, toxic, arsenic-based drug that was commonly used before.

Pediatric dosage form of benznidazole was added to the EMLc for the treatment of Chagas disease (American trypanosomiasis) in children. This child-adapted formulation of benznidazole - the main drug used to treat Chagas disease - was developed in partnership with Lafepe (Brazil) as an easily dispersible tablet for simple and accurate oral use in young children. The treatment was registered in Brazil in 2011.

"Children are often the first victims of parasitic diseases in developing countries, so we are very pleased that three life-saving, neglected-disease treatments for pediatric use, developed by DNDi and our partners, have been added to the WHO's Essential Medicines Lists,"  says Dr. Bernard Pécoul, executive director of DNDi. "This will facilitate access, quick adoption, and use by endemic countries to ensure they benefit young patients most in need."

Updated every two years, the WHO's EML and EMLc serve as critical guides for informing country-level essential medicine lists, procurement and supply of medicines, and clinical decision-making.

The inclusions of these new pediatric therapeutic options to the WHO EMLc attest to the urgent, specific treatment needs of children threatened by neglected diseases such as African sleeping sickness and Chagas disease, and highlight the leading public-goods product-development work of DNDi in the area of pediatric research and development (R&D) for neglected diseases and patients.