• DNDi-20_Logo_No-Tagline_EN_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
  • DNDi-20_Logo_No-Tagline_EN_Full Colour
  • Our work
    • Diseases
      • Sleeping sickness
      • Visceral leishmaniasis
      • Cutaneous leishmaniasis
      • Chagas disease
      • Filaria: river blindness
      • Mycetoma
      • Paediatric HIV
      • Cryptococcal meningitis
      • Hepatitis C
      • Dengue
      • COVID-19
      • Antimicrobial resistance
    • Research & development
      • R&D portfolio & list of projects
      • Drug discovery
      • Translational research
      • Clinical trials
      • Registration & access
      • Treatments delivered
    • Advocacy
      • Open and collaborative R&D
      • Transparency of R&D costs
      • Pro-access policies
  • Networks & partners
    • Partnerships
      • Our partners
      • Partnering with us
    • Global networks
      • Chagas Platform
      • HAT Platform
      • HELP Helminth Elimination Platform
      • LEAP Platform
      • redeLEISH Network
    • DNDi worldwide
      • DNDi Switzerland
      • DNDi DRC
      • DNDi Eastern Africa
      • DNDi Japan
      • DNDi Latin America
      • DNDi North America
      • DNDi South Asia/India
      • DNDi South-East Asia
      • DNDi Southern Africa
  • News & resources
    • News & stories
      • News
      • Stories
      • Statements
      • Viewpoints
      • Social media
      • eNews Newsletter
    • Press
      • Press releases
      • In the media
    • Resources
      • Scientific articles
      • Our publications
      • Videos
    • Events
  • About us
    • About
      • Who we are
      • How we work
      • Our strategy
      • Our donors
      • Annual reports
    • Our people
      • Our leadership
      • Our governance
      • Contact us
    • Work with us
      • Working at DNDi
      • Job opportunities
      • Requests for proposal
  • Donate
Home > Press releases

U.S. FDA approves Chemo Group’s benznidazole to treat children with Chagas disease

Home > Press releases

U.S. FDA approves Chemo Group’s benznidazole to treat children with Chagas disease

The triatomine bug, known as the “kissing bug,” is found from the Southern United States to southern Argentina.
The triatomine bug, known as the “kissing bug,” is found from the Southern United States to southern Argentina.
Washington DC, USA / Geneva, Switzerland — 31 Aug 2017
Share on twitter
Share on facebook
Share on linkedin
Share on email
Share on print
  • English
    • English
    • Español
    • Português

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

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

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

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

DNDi

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

Contact:

media@dndi.org

Policy advocacy Partnership Chagas disease

Read, watch, share

Loading...
Woman standing in front of a house
Press releases
2 Feb 2023

Dutch government renews support to DNDi projects on poverty-related diseases that disproportionately impact women

Statements
1 Feb 2023

DNDi interventions at the 152nd session of the WHO Executive Board

Young man sitting in hospital setting
News
25 Jan 2023

It’s time medical innovation reached the 1.7 billion people affected by neglected tropical diseases: World NTD Day 2023

Film Poster Voices of Leishmaniasis: Shushi from India
Videos
25 Jan 2023

Voices of leishmaniasis: Shishu from India

Child receiving treatment
News
20 Jan 2023

DNDi’s 20th year of bringing the best science for the most neglected

Child affected by dengue and her mother at their home in Bangkok, Thailand.
Stories
16 Dec 2022

2022: Six advances in neglected disease research to remember

Statements
2 Dec 2022

DNDi‘s comments on the conceptual zero draft for the consideration of the Intergovernmental Negotiating Body at INB3

Healthcare workers discussing in hospital setting
Press releases
1 Dec 2022

DNDi partners in a new NIHR-funded Global Health Research Group on HIV-associated Fungal Infections (IMPRINT)

VIEW ALL

Help neglected patients

To date, we have delivered twelve new treatments, saving millions of lives.

Our goal is to deliver 25 new treatments in our first 25 years. You can help us get there. 

GIVE NOW
Facebook-f
Twitter
Instagram
Linkedin-in
Youtube
International non-profit developing safe, effective, and affordable treatments for the most neglected patients.

Learn more

  • Diseases
  • Neglected tropical diseases
  • R&D portfolio
  • Policy advocacy

Get in touch

  • Our offices
  • Contact us
  • Integrity Line

Support us

  • Donate
  • Subscribe to eNews

Work with us

  • Join research networks
  • Jobs
  • RFPs
  • Terms of Use   
  •   Acceptable Use Policy   
  •   Privacy Policy   
  •   Cookie Policy   
  •   Our policies   

  • Except for images, films and trademarks which are subject to DNDi’s Terms of Use, content on this site is licensed under a Creative Commons Attribution-NonCommercial-Share Alike 3.0 Switzerland License   
We use cookies to track our audience and improve our content. By clicking 'Accept All', you are agreeing to our use of cookies. Click on 'Customize' to accept only some cookies.
Customize
ACCEPT ALL
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-advertisement1 yearSet by the GDPR Cookie Consent plugin, this cookie is used to record the user consent for the cookies in the "Advertisement" category .
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
CookieLawInfoConsent1 yearRecords the default button state of the corresponding category & the status of CCPA. It works only in coordination with the primary cookie.
PHPSESSIDsessionThis cookie is native to PHP applications. The cookie is used to store and identify a users' unique session ID for the purpose of managing user session on the website. The cookie is a session cookies and is deleted when all the browser windows are closed.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
CookieDurationDescription
elementorneverThis cookie is used by the website's WordPress theme. It allows the website owner to implement or change the website's content in real-time.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
CookieDurationDescription
_ga2 yearsThe _ga cookie, installed by Google Analytics, calculates visitor, session and campaign data and also keeps track of site usage for the site's analytics report. The cookie stores information anonymously and assigns a randomly generated number to recognize unique visitors.
_ga_16Q5RH3XRG2 yearsThis cookie is installed by Google Analytics.
_gat_UA-10302561-11 minuteA variation of the _gat cookie set by Google Analytics and Google Tag Manager to allow website owners to track visitor behaviour and measure site performance. The pattern element in the name contains the unique identity number of the account or website it relates to.
_gid1 dayInstalled by Google Analytics, _gid cookie stores information on how visitors use a website, while also creating an analytics report of the website's performance. Some of the data that are collected include the number of visitors, their source, and the pages they visit anonymously.
_hjAbsoluteSessionInProgress30 minutesHotjar sets this cookie to detect the first pageview session of a user. This is a True/False flag set by the cookie.
_hjFirstSeen30 minutesHotjar sets this cookie to identify a new user’s first session. It stores a true/false value, indicating whether it was the first time Hotjar saw this user.
_hjIncludedInPageviewSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's pageview limit.
_hjIncludedInSessionSample2 minutesHotjar sets this cookie to know whether a user is included in the data sampling defined by the site's daily session limit.
_hjSession_112884430 minutesHotjar sets this cookie.
_hjSessionUser_11288441 yearHotjar sets this cookie.
CONSENT2 yearsYouTube sets this cookie via embedded youtube-videos and registers anonymous statistical data.
Targeting
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
SAVE & ACCEPT
Powered by CookieYes Logo