On August 29th, the U.S. Food and Drug Administration (FDA) approved Chemo Research’s New Drug Application (NDA) for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.
Benznidazole is an essential medicine for Chagas disease, a dangerous parasitic disease that affects an estimated 6 to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.
“The approval of benznidazole represents a major milestone in the US and global response to address Chagas disease,” said Nick Haggar, CEO of Chemo Group. “We are excited to have the opportunity to fulfil this medical need and make a meaningful difference in the lives of Chagas patients. The FDA’s decision approves benznidazole for children ages 2-12 years old. We look forward to continuing our strong collaboration with the FDA to expand indication.”
Chemo Group played a central role in registering benznidazole with the FDA, in close collaboration with its US-based pharmaceutical division Exeltis, corporate social responsibility partner Mundo Sano, with the support of the Drugs for Neglected Diseases initiative (DNDi), a non-profit drug development organization. DNDi supported U.S. registration through provision of technical expertise and sharing of data from DNDi-led clinical trials. The approval of benznidazole will facilitate the delivery of life-saving medical treatment to people with Chagas disease.
“I am thrilled that we are taking a giant step forward in our journey to overcome the many barriers to Chagas treatment,” said Dr. Silvia Gold, President of Mundo Sano. “I would like to express my heartfelt thanks to the caring and dedicated doctors who fight for Chagas patients each day. I also send a warm thank you to all the researchers and experts diligently working to expand knowledge and understanding of this complex disease. It is a privilege to celebrate this milestone together with a passionate, dedicated community. Our work does not stop here, and we will work hand in hand to transform the lives of people suffering from Chagas disease.”
According to the terms of the collaboration between Chemo, Mundo Sano and DNDi, a substantial part of any revenue derived from the future sale of the PRV will be directed towards enhancing access to treatment for Chagas patients and improving patient health in other disease areas.
“We are proud to work together with the talented pool of doctors, experts and healthcare providers to ensure widespread use and equitable access for all patients,” said Fernando Mateus, President of Exeltis USA, Inc.
“Very few people with Chagas disease have access to treatment globally, and in the U.S. only a handful,” said Dr. Bernard Pécoul, 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.”
Looking ahead, Chemo Group will continue working in collaboration with Exeltis, Mundo Sano and Drugs for Neglected Diseases initiative (DNDi) to overcome barriers to treatment of Chagas disease. Exeltis will be responsible for the product distribution in the US market. In parallel, Mundo Sano and DNDi will pursue efforts to boost access and increase patient awareness.