Develop and register formulations of benznidazole for treating infants and children with Chagas disease
current phase of drug development
updated 1 Jun 2021
Treatment gap closed for children with Chagas disease
Until 2011, benznidazole, the main drug of choice for treating Chagas disease, was only available in an adult-strength tablet. Infants and children were treated with divided or crushed adult tablets, which was complicated for caregivers and resulted in inconsistent dosing.
The paediatric formulation of benznidazole is an affordable, easy to use, non-patented dispersible tablet designed for infants and children up to two years of age (less than 20 kg). It was added to the WHO Essential Medicines List for Children in 2013.
The tablet dissolves easily so that treating young children is simpler. There is no need to divide tablets, except for low-birth-weight babies weighing less than 2.5 kg. The paediatric formulation improves dosing accuracy, safety, and adherence to treatment.
Treatment regimens
- Indication: Chagas disease in children
- Dosage: Child-adapted dose of 12.5 mg per tablet (twice daily for 60 days)
Impact
Registered in Brazil in 2011
- First paediatric Chagas disease drug granted registration by Brazil’s National Health Surveillance Agency (ANVISA)
- Result of a three-year collaborative partnership, starting in 2008, between DNDi and Pernambuco State Pharmaceutical Laboratory (LAFEPE from Laboratório Farmacêutico do Estado de Pernambuco) of Brazil
Registered in USA in 2017
- Benznidazole is the first drug ever approved by the US FDA to treat Chagas disease
- The FDA approved benznidazole to treat children aged 2-12 years, comprising 12.5 mg (developed by DNDi and partners) and 100 mg tablets
- Result of a partnership between DNDi, Chemo Research, Exeltis USA, and Mundo Sano Foundation
- With approval, the FDA granted Chemo Research a neglected tropical disease priority review voucher (PRV)
- 50% of PRV proceeds to be used to enhance access to Chagas treatment
Registered in Argentina in 2018
- Granted registration by Argentina’s National Health Surveillance Agency (ANMAT)
- Result of a collaboration agreement signed in November 2013 between Mundo Sano Foundation and DNDi, in partnership with Laboratorio ELEA PHOENIX (producers of Abarax®)
- The partnership aims to enable broader registration in disease-endemic countries, with a commitment to wider availability of the paediatric dosage form
‘I found out I had Chagas and after that, I got pregnant. The test was positive for my baby too. We started his treatment right away, despite our fears. Today we found out that he is cured!’
María Corina
Project updates
2018
The paediatric formulation of benznidazole, the main drug of choice for treating Chagas disease, was registered in Argentina in 2018. This was the result of a partnership between Fundación Mundo Sano, DNDi and Laboratorio Elea Phoenix to enable registration in more disease-endemic countries and provide a second source of the drug. The paediatric formulation of benznidazole was developed through a collaboration between DNDi and Laboratório Farmacêutico do Estado de Pernambuco (LAFEPE) of Brazil and was first registered in 2011, in Brazil. It improves accuracy, safety, and adherence to treatment for children under two years of age (or up to 20 kg).
2017
DNDi and the Mundo Sano Foundation collaborated with ELEA to deliver and register a second source of the paediatric treatment against Chagas (Abarax© 12.5mg tablets). The registration process for regulatory approval in Argentina is ongoing. The first paediatric formulation was registered in Brazil in 2011, developed by DNDi and LAFEPE to address infants and children up to two years old. The treatment was included in the WHO Essential List for Children two years later.
2016
Following the registration in 2011 in Brazil of the paediatric dosage form of benznidazole that was developed by DNDi and LAFEPE to address babies and children up to two years of age’s needs, and the inclusion in 2013 of the treatment on the WHO Essential List for Children, the main objective has been to broaden availability of the product. To this end, DNDi and the Mundo Sano Foundation entered into collaboration with ELEA to deliver and register a second source of the treatment (Abarax© 12.5mg tablets). The submission process for regulatory approval in Argentina was still ongoing in 2016.
News & resources
- 31 May 2023 – Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation, PLOS Neglected Tropical Diseases
- 13 April 2018 – Drug approved in Argentina for treatment of Chagas disease in children
- 31 August 2017 – U.S. FDA approves Chemo Group’s benznidazole to treat children with Chagas disease
- 8 June 2016 – DNDi, Mundo Sano and Chemo team up to register benznidazole in US and Latin America
- 11 November 2013 – Mundo Sano and DNDi Join Forces to Provide Access to Treatments for Chagas Disease Patients
- 11 July 2013 – Three Neglected-Disease Treatments Newly Added to WHO Essential Medicines List for Paediatric Use
- 2 December 2011 – New Child-Adapted Chagas Disease Treatment Approved for Registration
- 21 July 2008 – Chagas Disease Partnership Will Deliver Safe, Easy-to-Use Treatment for Children
Additional information
Poster
Population Pharmacokinetics of Benznidazole in Children with Chagas’ Disease
by Altcheh J, Ribeiro I, Alves F, Caruso M, Monla C, Ledesma Patiño O, Garcia-Bournissen F
Launch dossier 2011:
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