The FDA registers the first drug ever approved in the U.S. to treat Chagas disease

The registration of Benznidazole for children means a step forward to overcome many barriers to treatment.

31 August 2017

 

The news of Benznidazole in the U.S. means “a giant step forward in our journey to overcome the many barriers to Chagas treatment,” said Dr. Silvia Gold, President of Mundo Sano Foundation, the social branch of Chemo Group (producer of benznidazole, one of the only two drugs available for Chagas disease)

On August 29th, some weeks after Mexico decided to register benznidazole, the U.S. Food and Drug Administration (FDA) also approved it, being the first drug ever registered by the US FDA to treat Chagas disease. With more than 6 million people affected in the world, there are around 300.000 of them in the United States.

Dr. Silvia Gold recognized the constant work of the whole Chagas community which has contributed to this news. At the moment, the registration of benznidazole in the U.S. only applies for treatment of children between 2 and 12 years old. Nick Haggar, Chemo’s CEO, shared his satisfaction in a press release: “We are excited to have the opportunity to fulfill this medical need and make a meaningful difference in the lives of Chagas patients”. He confirmed his will to “continuing the collaboration with the FDA to expand indication to adults.”

This new stage in the fight against Chagas has been possible due to the collaboration of Chemo Group and its branch in the US (Exeltis), together with Mundo Sano and Drug for Neglected Diseases initiative (DNDi), both founding members of the Chagas Coalition and partners and providers of technical information and data sharing from clinical trials.

 

With the registration of benznidazole, the FDA also provides a priority review voucher (PRV), a mechanism developed for stimulating the R+D of neglected diseases. The agreement of Chemo, Mundo Sando and DNDi will provide some revenues from the PRV towards enhancing access to treatment for Chagas patients and improving patient health in other disease areas.

Very few people with Chagas disease have access to treatment globally, and in the U.S. only a handful,” said Dr. Bernard PĆ©coul, DNDi Executive Director. “It is our hope that FDA registration will also catalyze endemic countries in Latin America that have not yet registered the drug to do so. Ultimately, we believe this will help transform the dynamic of access to treatment throughout the Americas.”

The news of the registration of Benznidazole in the U.S. came after the registration in Mexico, which was announced by Marcelo Abril, director of Mundo Sano, which brings great expectations for scaling up access in endemic countries.

Taking into account that today less than 1% of the population in need have access to their treatment, the Chagas Coalition welcomes the news of the registration of benznidazole for the possible benefits of patients in both endemic and non-endemic countries.