[Ip-health] DNDi: New Child-Adapted Chagas Disease Treatment Approved for Registration

Rachel M. Cohen rachel.cohen72 at gmail.com
Fri Dec 2 16:23:21 PST 2011

Dear colleagues, 


Please find below an announcement today by the Drugs for Neglected Diseases
initiative (DNDi) and partners on the registration of pediatric benznidazole
for the treatment of young children with Chagas disease.


Press release link:


English: http://dndi.org/press-releases/1016-paedbenz.html

Español (Spanish): http://dndi.org/press-releases/1017-benzped.html 

Português (Portuguese):





New Child-Adapted Chagas Disease Treatment Approved for Registration


Rio de Janeiro and Recife, Brazil, and Geneva, Switzerland – 2 December 2011


Today, at the occasion of the 4th DNDi Partners’ Meeting in Rio de Janeiro,
Brazil, Dr Carlos Gadelha, Secretary of Science, Technology and Strategic
Products, Brazilian Ministry of Health, announced that Brazil’s National
Health Surveillance Agency (ANVISA) granted registration of a new paediatric
dosage form of benznidazole, developed through a partnership between the
Pernambuco State Pharmaceutical Laboratory (LAFEPE) of Brazil and the Drugs
for Neglected Diseases initiative (DNDi). Registration of this child-adapted
formulation of benznidazole will be published on 12 December 2011.


This new tablet means easier-to-administer and safer treatment of Chagas
disease in infants and young children under the age of two, as they will
receive accurate dosage. 


Until today, benznidazole was available only as a 100-mg tablet for adults.
Treatment for young children required cutting adult pills into tiny slivers
– up to 12 pieces depending on the child’s weight – and crushing and mixing
them with water or juice, to be administered twice a day for 60 days. This
difficult and inefficient method often results in improper dosing, risks of
increased side-effects or ineffective treatment, and treatment stoppages. 


Chagas disease infects an estimated 8 to 10 million people, mostly in Latin
America, and kills some 12,000 people each year, making it the leading
parasitic killer in the Americas, where it causes more deaths than malaria.
The Chagas parasite is primarily transmitted via the bite of the
blood-sucking triatome bug, widely known as the ‘kissing bug’, which is
often found in poor housing conditions. In addition to blood transfusion,
organ transplant, or ingesting infected food, the parasite is also
transmitted during pregnancy from mother to child. 


This new dosage form for children represents real progress for several
reasons. Children are at especially high risk of infection, with a majority
of them born from infected mothers. It is known that early treatment using
benznidazole in the first year of life can eliminate the parasite in more
than 90% of infected newborns. Thus, babies infected with Chagas disease
will benefit the most from this new paediatric tablet. 


‘Thousands of mothers with Chagas disease-infected babies will welcome this
as more than just a pill’, says Manuel Gutiérrez, President of the
International Federation of Chagas Patients. ‘Their voices have finally been


The new 12.5-mg tablet is easily dispersible (disintegrated) and adapted for
babies and children up to two years of age (20 kg body weight). Treatment is
designed to use one, two, or three tablets, depending on weight (recommended
dosage, 5-10 mg/kg bodyweight/day).


‘The presentation of this paediatric dosage form of benznidazole, as a final
result of the collaborative project between DNDi and LAFEPE, opens
possibilities for effective treatment [
] for thousands of children’, says
Dr Mirta Roses Periago, Director of the Pan American Health Organization
(PAHO). ‘From now on, hope of an early cure for infection of the parasite
that causes Chagas disease is a wonderful reality.’


Tools to facilitate implementation of and access to the new treatment
include a Demand Forecast, a Procurement Guide, and a Tool Box providing
training and educational materials for doctors, other health professionals,
mothers, and caregivers regarding appropriate use of the treatment. 


In 2008, DNDi and LAFEPE entered a joint development agreement for this
dosage form. The new tablet will be produced by LAFEPE, a public
pharmaceutical manufacturer run by the State of Pernambuco in Brazil and the
sole global producer of benznidazole. 


‘We will exert all efforts, regarding commercial aspects, towards rapid
patient access of this drug’, says Luciano Vasquez, President of LAFEPE. ‘It
will be offered at cost to all public health institutions, including the
Ministry of Health of Brazil.’ Indeed, the paediatric dosage form will also
be made available at cost to non-governmental organizations and
philanthropic institutions.


The new paediatric dosage form has been granted registration from Brazil’s
National Health Surveillance Agency (ANVISA), and DNDi is collaborating with
LAFEPE to make the drug widely available, notably by working to register the
drug in Argentina, Bolivia, Colombia, and Paraguay – priority countries
where Chagas disease prevalence is high and treatment is urgently needed.


‘At a time when efforts are being made to secure production of benznidazole,
we must ensure that this new product is made available in all endemic areas
and that treatment of children is rapidly expanded, in addition to the
treatment of adults’, says Dr Bernard Pécoul, Executive Director of DNDi.
‘With this new tablet, we can reach a turning point for the treatment of
children infected with Chagas disease and we have to move rapidly to get the
drug to them.’ 


The project received funding support from the Department for International
Development (DFID), UK; the Dutch Ministry of Foreign Affairs (DGIS), The
Netherlands; Médecins Sans Frontières/Doctors without Borders
(International, Italy, Brazil); the Spanish Agency for International
Development Cooperation (AECID), Spain; the Swiss Agency for Development and
Cooperation (SDC), Switzerland; the United States Agency for International
Development, via the 4th Sector Health Project implemented by Abt
Associates, Inc.; Swiss private foundations and individual donors.




About Chagas Disease

Chagas disease (American trypanosomiasis) infects an estimated 8 to 10
million people, mostly in Latin America, where it is endemic in 21
countries. It kills some 12,000 people each year, making it the leading
parasitic killer in the Americas. The people most affected by the disease
are very poor and live in inadequate housing conditions and often have
little access to healthcare. Cases are also rising in North America, Europe,
Japan, and Australia. Caused by the parasite Trypanosoma cruzi, Chagas
disease starts with an early, acute stage lasting about two months, and is
followed by a late, chronic stage lasting through lifetime, in which up to
30% of patients develop heart damage and up to 10% may have severe damage to
their digestive system. In early adulthood, patients with these symptoms
ultimately die, usually from heart damage. The Chagas parasite is primarily
transmitted via the bite of the blood-sucking triatome bug, sometimes called
the ‘kissing bug’. Chagas is also transmitted by blood transfusion, organ
transplantation, oral ingestion, or during pregnancy from mother to newborn.
The latter, congenital Chagas disease, is considered to represent the most
important mode of transmission of the coming years, and it is estimated that
over 14,000 new such cases occur annually.



Pernambuco State Pharmaceutical Laboratory (Laboratório Farmacêutico do
Estado de Pernambuco; LAFEPE) is the second largest public laboratory in
Brazil. LAFEPE was created in 1966 to produce medicines at low cost for
people with limited purchasing power. Based in Recife, the capital of the
state of Pernambuco in northeastern Brazil, LAFEPE focuses on developing,
producing, and marketing drugs to support the needs of public health policy.
For example, in 1994, it became the first official laboratory in Brazil to
produce the antiretroviral zidovudine (AZT). The Pernambuco laboratory
invests in the modernization of its facilities, with high-tech industrial
equipment. Its pioneering programme, ‘Popular Pharmacy’, set up in popular
market areas in different regions of the state, serves as a model for the
federal government.  www.lafepe.pe.gov.br


About DNDi

The Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit
research and development organization working to deliver new treatments for
neglected diseases, in particular sleeping sickness (human African
trypanosomiasis), Chagas disease, leishmaniasis, specific helminth
infections, and paediatric HIV. DNDi was established in 2003 by Médecins
Sans Frontières/Doctors Without Borders (MSF), Oswaldo Cruz Foundation
(FIOCRUZ) from Brazil, Indian Council for Medical Research (ICMR), Kenya
Medical Research Institute (KEMRI), Ministry of Health of Malaysia, and
Pasteur Institute of France. The Special Programme for Tropical Disease
Research (TDR) serves as a permanent observer. Since 2003, DNDi has
delivered five new treatments for neglected patients: two fixed-dose
antimalarials (ASAQ and ASMQ), nifurtimox-eflornithine combination therapy
(NECT) for late-stage sleeping sickness, sodium stibogluconate and
paromomycin (SSG&PM) combination therapy for visceral leishmaniasis in
Africa, and a set of combination therapies for visceral leishmaniasis in
Asia.  The new paediatric dosage form of benznidazole is now the sixth
treatment delivered by DNDi since its inception eight years ago.


Media contacts:

DNDi Latin America, Rio de Janeiro (Spanish, Portuguese, English): Flavio
Pontes (on site)

office: +55 21 2215 2941 / mobile: +55 21 8123 4133 / email:
press at dndi.org.br 


DNDi International, Geneva (French, English): Violaine Dällenbach

office: +41 22 906 92 47 / mobile: +41 79 424 14 74 / email:
vdallenbach at dndi.org


DNDi North America, New York (English): Oliver Yun

office: +1-646-616-8681 / mobile: +1-646-266-5216 / email: oyun at dndi.org





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