8 November 2017 | Geneva −− The World Health Organization (WHO) and the Mundo Sano Foundation are working to make an essential antiparasitic medicine for treatment of Chagas disease widely accessible to children. Treatment with benznidazole in the early stages of infection can cure the Chagas disease, but currently very few people are able to access diagnosis and treatment services.
“We are working to enhance access to this medicine to people who need it the most,” said Silvia Gold, President of Mundo Sano Foundation.1 “We are proud to have Insud Pharma2 as a reliable industrial partner capable of expanding quality-assured affordable benznidazole. Our hope is to transform the dynamic of access to treatment for Chagas disease patients throughout the Americas and beyond..”
Benznidazole is commonly used as a first-line treatment for Chagas disease. Although it has existed for more than 40 years, it was not registered by any of the world’s regulatory agencies. It was only in August 2017 that the United States Food and Drug Administration (FDA) approved benznidazole for the treatment of children aged 2–12, making it the first treatment approved in the United States for Chagas disease.
“The cure rate for Chagas disease is almost 100% if treatment occurs early after infection, particularly in the early years of life,” said Dr Pedro Albajar Vinas, Medical Officer with WHO’s Department of Control of Neglected Tropical Diseases. “For cases in children born from infected mothers – as high as 15 000 new cases per year – a paediatric presentation with improved dosing accuracy will greatly help in the treatment of congenital infections.”.
Benznidazole is manufactured by Chemo Research (a division of Insud Pharma). The decision by the FDA makes benznidazole the first medicine to be approved to treat Chagas disease in the United States, where at least 300 000 people are estimated to be affected by the disease. In reality, the total population is likely to more than double this number if all affected persons are taken into account.
Insud Pharma – a major Spanish pharmaceutical company – played a central role in the FDA registration of benznidazole and worked closely with its US-based pharmaceutical division Exeltis and its corporate social responsibility partner the Mundo Sano Foundation. The Drugs for Neglected Diseases initiative (DNDi), among others, provided technical support to the Chemo Group to analyse and present the information requested by the FDA. In vitro and in vivo tests were performed by Insud Pharma.
The approval now facilitates delivery of treatment to hundreds of thousands of people.
Chagas disease is found mainly in endemic areas of 21 Latin American countries3 where infection is transmitted mostly by vectors to humans by contact with faeces or urine of triatomine bugs (also known as “kissing bugs” among many other names), depending on the geographical area.
For centuries, the disease was strictly a Latin American disease of rural populations. The exodus from rural towards suburban and urban areas and to other continents has expanded the reach of disease transmission channels towards non vectorial routes, such as blood transfusion, congenital transmission and organ transplants.
In previous decades, Chagas disease was increasingly detected in the United States of America and Canada and in many European and some Western Pacific countries due mainly to population mobility mostly migration. However, cases of infection have been reported among travellers returning from Latin America and even in adopted children.
About 6 to 7 million people worldwide are estimated to be infected with Trypanosoma cruzi, the parasite that causes Chagas disease.
Vector control remains the most effective method of preventing transmission in Latin America.
There is no vaccine for Chagas disease, named after Carlos Ribeiro Justiniano Chagas, a Brazilian physician and researcher who discovered the disease in 1909.
Mundo Sano is a nonprofit international foundation working with the public and private sectors, academia, and other international organizations to provide solutions to the affected communities and generate scientific knowledge. In 2012, it led a public-private consortium in 2012 to produce benznidazole in Argentina.
2Insud Pharma (formerly known as Chemo Group) specializes in research, development, manufacture, sale and marketing of active pharmaceutical ingredients and medicinal products for human and veterinary use.
3Argentina, Belize, Bolivia (Plurinational State of), Brazil, Chile, Colombia, Costa Rica, Ecuador, El Salvador, French Guiana, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay and Venezuela (Bolivarian Republic of).