references
R&D MODEL & PORTFOLIO
CHAGAS DISEASE
IMPLEMENTATION
Paediatric Dosage Form of Benznidazole
PROJECT START: May 2011 OVERALL OBJECTIVE: Develop and make available an easily dispersible, simpler to administer, safer, age-adapted dosage for children under two years old 2015 OBJECTIVES:
• Ensure paediatric benznidazole is available in endemic countries in Latin America and together with ELEA • Submit a regulatory dossier for second source of paediatric benznidazole
In July 2008, DNDi and LAFEPE entered a joint development programme that led to the determination and production of the most appropriate paediatric dosage formulation, strength, and dosing regimen of benznidazole. A population pharmacokinetic study in children aged 0 to 12 years with Chagas disease was conducted and showed complete parasitic clearance in all children immediately after treatment. Sustained response at 12 months was assessed in a subset of patients with longer follow-up. The study also showed that children have lower
blood levels of benznidazole than previously documented in adults, suggesting that reduced adult dose regimen should be considered for evaluation. An easy to use and adapted paediatric dosage form was developed and registered in Brazil (2011), and subsequently included on the WHO Essential Medicines List for children (2013). The Mundo Sano Foundation and DNDi signed a collaboration agreement (2013) to deliver a second source of the treatment in partnership with ELEA. ELEA produced pilot and scale-up batches in 2014, and stability testing is underway. Submission for marketing authorization was carried out by ELEA in Argentina at the end of 2015, and will proceed in other endemic countries. Through this project, DNDi has also stepped up efforts to support the scale up of treatment with benznidazole for adult patients with Chagas disease.
MAIN PARTNERS: BRAZIL: LAFEPE; ARGENTINA: Fundación Mundo
Sano and ELEA; Centro Nacional de Diagnóstico e Investigación de Endemo-epidemias (CeNDIE), Administración Nacional de Laboratorios e Institutos de Salud (ANLIS); 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; Ministry of Health; Ministério de Salud, Província de Jujuy
40 › DNDi Annual Report 2015
