Argentina has approved the paediatric indication of a drug used for treatment of Chagas disease, benznidazole, which will now be available in 12.5 mg pills, the dose required to treat children under the age of 2. The indication was approved by the Argentinian National Administration for Drugs, Food, and Medical Technologies (ANMAT).
According to the World Health Organization (WHO), Chagas disease affects more than 6 million people in the world, of whom more than 1.2 million are childbearing-age women. Every year nearly 9,000 infants are born with Chagas disease through vertical transmission (children infected by the transplacental route from infected mothers).
“The advantage of a 12.5 mg pill for children is that the treatment dosage can be adjusted adequately, thus decreasing the risk of adverse effects in the paediatric population,” said Dr. Jaime Altcheh, Head of the Chagas Parasitology Service of the Dr. R. Gutiérrez Children’s Hospital and Director of the PAHO/WHO Collaborating Center for Chagas Disease. “Studies conducted at the Dr. Ricardo Gutiérrez Children’s Hospital showed that newborns and infants have different metabolism of the drug when compared to adults: lower plasma concentrations of benznidazole provide excellent therapeutic results in children, so the new presentation makes a significant contribution to treatment of paediatric Chagas,” he emphasized.
Development of the 12.5 mg paediatric formulation of benznidazole began in Argentina through an agreement between Fundación Mundo Sano (FMS) and the Drugs for Neglected Diseases Initiative (DNDi) in 2013 to guarantee treatment of children 0 to 2 years of age.
Fundación Mundo Sano has developed extensive work with Chagas disease and is committed to maintaining this work in the future. It has currently signed a Cooperative Agreement with the Pan American Health Organization (PAHO) to facilitate access to treatment for congenital Chagas. “Today, mother-to-child transmission is the leading cause of new cases worldwide. In Argentina, more than 1,300 children are born with Chagas disease every year. Thus, treating children and childbearing-age women is the key to controlling the disease, and that is our main challenge for the immediate future,” stated Marcelo Abril, Executive Director of Fundación Mundo Sano.
The World Health Organization has included benznidazole on its list of essential drugs. Benznidazole is registered in the majority of the endemic countries in Latin America. Elea-Phoenix is certified by PAHO as the only global manufacturer with good manufacturing practices (GMP) for the product.
“We have been committed since the beginning to provide solutions for people with Chagas. In 2012, ANMAT approved Abarax® (benznidazole) in 50 mg and 100 mg pills with double grooves, which had a high impact given the global shortage of the drug,” said Luis Ferrero, Executive Manager of the Elea-Phoenix Laboratory. “With this new presentation, we feel proud to once again respond to a global medical need and facilitate treatment for the paediatric population with Chagas,” he highlighted.
Chagas disease is one of the main public health problems in Latin America, and very few people with Chagas have access to treatment. Given this reality, Fundación Mundo Sano and DNDi committed to join forces to provide patients with access to treatments for Chagas disease. “Medical evidence shows the efficacy of benznidazole in the treatment of Chagas disease. Our collective effort is to guarantee that patients have access to existing treatment, while we continue in our active search for new health tools,” said Michel Lotrowska, interim Executive Director of DNDi Latin America.
About Elea Phoenix
With a track record of more than 75 years, Elea Phoenix researches and develops reliable drugs for a variety of medical specialties. It is one of the foremost pharmaceutical companies in Argentina and has leading brands, innovative R & D projects, and licenses from the leading international companies. With its own manufacturing plants and a wide distribution network, the company focuses on the development of new products, especially in the areas of Women’s Health, Cardiology, Neurosciences, Oncology, and over-the-counter drugs. For more information, see: www.elea.com
About Mundo Sano
Mundo Sano is a non-profit foundation whose vision since 1993 has been to reduce the impact of neglected tropical diseases. The foundation works jointly with the public and private sectors, academia, and other international organizations, seeking to improve equitable access to healthcare. In 2012, Mundo Sano led a public-private consortium in Argentina to produce benznidazole, one of the existing drugs for treatment of Chagas disease. For more information, see: www.mundosano.org
About DNDi
DNDi is a non-profit research and development organization that works to offer new treatments for neglected tropical diseases. DNDi participates actively in the development of new treatments and in the detection of new compounds for Chagas disease. DNDi and its partners presented the first pediatric dosage of benznidazole and are conducting clinical trials to assess new regimens and combinations of the drug. DNDi is also fully involved in the preliminary research into completely new drugs for Chagas disease. For more information, see: www.dndial.org
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Photo credit: João Roberto Ripper
