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 fulfill 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.”
With the approval of benznidazole, the FDA granted Chemo Research a neglected tropical disease priority review voucher (PRV). 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.
Chemo Group is a global pharmaceutical company with over 40 years of experience and commitment in safeguarding and improving people’s health and well-being. The Chemo Group has offices in more than 40 countries in Europe, the Americas, Asia, and Africa, and employs more than 6,000 professionals. The Group’s 15 factories, 10 R&D centers, and 33 affiliated pharmaceutical companies provide high quality, accessible medicines and services to patients around the world while collaborating with more than 1150 pharmaceutical business partners in 96 countries. Chemo Research based in Spain and Madrid has played a central role in bringing benznidazole to the FDA for assessment and approval. www.chemogroup.com
Exeltis is a branded pharmaceutical division of the Chemo Group that specializes in Women’s Healthcare, Dermatology, Respiratory Disease and diseases of the Central Nervous System. Exeltis USA is located in New Jersey and is the market leader in PreNatal Vitamins and has a consolidated position in Women’s Healthcare and Dermatology. Exeltis USA will use its operational and technical platform to support the availability of benznidazole in the United States in support of Mundo Sano – to help minimize costs and ensure compliance with FDA regulations. www.exeltisusa.com
Mundo Sano is a nonprofit foundation whose vision is the transformation of the realities of the populations affected by neglected tropical diseases since 1993. In pursuit of achieving greater equity, the institution works alongside the public and private sectors, academia, and other international organizations. In order to provide solutions to the affected communities and generate scientific knowledge, Mundo Sano led a public-private consortium in 2012 to produce benznidazole in Argentina, one of the two drugs that treat Chagas disease. www.mundosano.org
A not-for-profit R&D organization, DNDi works to deliver new treatments for neglected tropical diseases. DNDi is actively engaged in developing new treatments and screening new compounds for Chagas disease. DNDi and partners delivered the first pediatric dosage form of benznidazole and are running clinical trials evaluating new regimens or combinations of the drug. DNDi is also involved in early stage research for entirely new drugs for Chagas disease. www.dndi.org