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DNDi Achievements

Paediatric benznidazole to treat Chagas disease Chagas disease

New, child-adapted formulation to treat Chagas

2011

 

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 easier. 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.

At a glance

  • Indication: Chagas disease in children
  • Dosage: Child-adapted dose of 12.5 mg per tablet (twice daily for 60 days)
  • Project start: 2011

Abarax

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 from 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 first drug ever approved by the US FDA to treat Chagas disease
  • 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 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®)
  • Partnership aims to enable broader registration in disease-endemic countries, with a commitment to wider availability of the paediatric dosage form

 

Paediatric Benznidazole Patients

“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

 

 

Partners

Brazil: LAFEPE; Argentina: Fundación Mundo Sano and Laboratorio ELEA PHOENIX; Centro Nacional de Diagnóstico e Investigación de Endemo-epidemias, Administración Nacional de Laboratorios e Institutos de Salud; Centro de Chagas y Patologia Regional, Hospital Independencia, Santiago del Estero; Hospital de Niños de Jujuy; Hospital de Niños Dr. Ricardo Gutiérrez; Hospital Público Materno Infantil – Salta; Instituto Nacional de Parasitología Dr M Fatala Chabén; Argentina Ministry of Health; Ministério de Salud, Província de Jujuy.

Funding

Associação Bem-Te-Vi Diversidade, Brazil; Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; Médecins Sans Frontières/Doctors without Borders, International, Italy, Brazil; Ministry of Health, Brazil; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Starr International Foundation, Switzerland; the United States Agency for International Development, via the 4th Sector Health Project implemented by Abt Associates, Inc., USA; Other private foundations and individuals.

 

 

Photo credit: Fábio Nascimento-DNDi

Last updated: October 2018