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March 14, 2019
En los medios

Approval of a medication for Chagas disease treatment in the pediatric population


Buenos Aires, April 2018 – Argentina approves the pediatric formulation of a drug used for Chagas disease treatment. Benznidazol, which will be available in 12.5 mg tablets, the dosage required to treat 0 to 2 year olds, was recently approved by the National Administration for Drugs, Food and Medical Technology (ANMAT, Spanish acronym).

According to the World Health Organization (WHO), the Chagas disease affects more than 6 million people in the world, half of which are women of childbearing age. Close to 9,000 children are born every year with Chagas disease due to vertical transmission (babies of infected mothers who fall victim to the disease through transplacental contagion). In Argentina, the population at risk of getting Chagas exceeds 7 million people, with 1.5 million already suffering it.

“The advantage of having a 12.5 mg tablet for children is that we can adjust treatment doses adequately, reducing the risk of undesired side effects on the pediatric population under treatment,” stated Dr. Jaime Altcheh, Head of the Parasitological-Chagas Service, “Dr.Ricardo Gutierrez” Children Hospital, and Director of the PAHO/WHO Pediatric Chagas Cooperation Center. “Studies conducted at the “Dr. Ricardo Gutierrez” Children Hospital have shown that newborns and infants have a drug-metabolizing system different from adults’, thus obtaining excellent therapeutic results with lower  benznidazol concentrations in blood, which makes this new formulation a very significant contribution to the treatment of this disease in children,” he added.

The development of Pediatric benznidazol, 12.5 mg  in Argentina started under an agreement between Fundación Mundo Sano (FMS)  and the Drugs for Neglected Diseases Initiative (DNDi) in 2013 aiming to secure treatment for children of 0 to 2 years of age.

Fundación Mundo Sano has been doing, and is committed to sustain in the future, extensive work in relation to Chagas disease. At present, it has a Cooperation Agreement with the Pan-American Health Organization (PAHO) to facilitate access to the treatment of congenital Chagas. “Nowadays, mother to baby transmission is the one that originates the largest number of cases at global level. In Argentina, more than 1,300 children are born with Chagas disease. For this reason, treating children and women with childbearing potential is key to disease control. This is our greatest challenge in the near future,” said Marcelo Abril, Executive Director, Fundación Mundo Sano.

Benznidazol has been included in the World Health Organization (WHO) Model List of Essential Medicines and is registered in the health organizations of most Latin American countries with endemic diseases, with Elea-Phoenix, as the PAHO certified laboratory and sole global producer working under Good Manufacturing Practices (GMP).

“From the beginning, we took over the commitment to give response to the population suffering Chagas disease. In 2012, the ANMAT approved Abarax® (benznidazol) in formulations with 50 mg and 100 mg pills with two crossed grooves, which had a high impact in light of world scarcity of this medicine,” said Luis Ferrero, Executive Manager, Elea-Phoenix Pharmaceutical. “With this new form, we are proud to give response to a global medical need and facilitate treatment of the pediatric population with Chagas,” he emphasized.

This disease is one of the most significant public health problems in Latin America and very few people with Chagas have access to treatment. Given this reality, Fundación Mundo Sano and the DNDi (Drugs for Neglected Diseases initiative) have agreed to join their efforts to provide Chagas patients access to treatment. “Medical evidences will show the effectiveness of benznidazol in the treatment of Chagas disease. Our joint efforts aim to assure that patients have access to existing treatment, while we keep on in our active search for new health tools,” said Michel Lotrowska, acting CEO of DNDi Latin America.

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