Sanofi: Fexinidazole, the first all-oral treatment for sleeping sickness, approved in Democratic Republic of Congo
30 Enero 2019 - 8:00AM
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Fexinidazole will contribute to international
efforts to eliminate sleeping sickness, a fatal neglected tropical
disease endemic to Africa, by 2020
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It is the first all-oral treatment for sleeping
sickness, and is effective for both stages of the disease
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Democratic Republic of Congo bears the majority
of the sleeping sickness disease burden, with around 85% of
reported cases
PARIS and GENEVA - January 30, 2019 -
Marketing authorization of fexinidazole for the treatment of
Trypanosoma brucei gambiense human African trypanosomiasis (HAT), more
commonly known as sleeping sickness, has been granted in the
Democratic Republic of Congo (DRC). This approval paves the way for
the distribution of fexinidazole in endemic countries this year,
with another submission planned in Uganda.
Sleeping sickness is usually fatal
without treatment. Transmitted by the bite of a tsetse fly, it
causes neuropsychiatric symptoms; including aggression, psychosis,
and a debilitating disruption of sleep patterns that have given
this neglected disease its name. About 65 million people in
sub-Saharan Africa are at risk.
"I have a
personal connection to sleeping sickness. Growing up in East
Africa, my mother was always worried that sleeping sickness would
impact us as a family," says Ameet Nathwani, M.D., Chief Medical
Officer and Executive Vice President Sanofi Medical. "The approval
of fexinidazole in the Democratic Republic of Congo gives me great
hope for our efforts to eliminate sleeping sickness by next
year."
The current treatment option for sleeping sickness, while
effective, was burdensome for patients and health workers -
requiring logistical challenges of hospitalization, especially
challenging for people living in remote areas.
Fexinidazole is approved in the
DRC as a 10-day once-a-day treatment for T.b.
gambiense sleeping sickness (the most common form of the
disease, found in West and Central Africa). Importantly,
fexinidazole is the first all-oral treatment that works both for
(i) the early stage of the disease as well as the (ii) second stage
of the disease in which the parasites have crossed the blood-brain
barrier, causing patients to suffer from neuropsychiatric symptoms.
Fexinidazole could, therefore, eliminate the need for patients'
systematic hospitalization.
On 16 November 2018, The European
Medicines Agency (EMA) adopted a positive scientific opinion of
fexinidazole - a result of clinical trials led by the non-profit
research and development organization the Drugs for Neglected
Diseases initiative (DNDi) and an application submitted by Sanofi.
"We look forward
to the implementation of fexinidazole as a first-line treatment and
welcome this rapid approval of fexinidazole in the DRC very shortly
after the EMA opinion, a testament to the dedication of the DRC
Government through the Ministry of Health to eliminate HAT as a
public health problem by 2020," says Dr Nathalie Strub-Wourgaft,
DNDi Director of Neglected Tropical Diseases. "This shows the value
of Article 58, an innovative regulatory mechanism intended for the
review of new medicines destined for use outside of the European
Union."
Sanofi had submitted a regulatory
dossier to the EMA under Article 58 of Regulation 726/2004 in
December 2017. By allowing for the participation of endemic
countries (DRC and Uganda) and of the WHO in the evaluation of the
fexinidazole regulatory dossier, approval under Article 58 also
facilitates and could accelerate future national product
registrations and patient access.
About sleeping
sickness
The majority of sleeping sickness
patients live in the Democratic Republic of Congo, where 85% of
Trypanosoma brucei gambiense sleeping sickness
cases were reported in 2017, followed by the Central African
Republic, Guinea and Chad. The latest data released by the WHO in
July 2018 confirm a sustained decrease in the number of new cases.
Only 1,447 new cases were reported to the WHO in 2017 compared to
2,164 cases in 2016 and 9,870 cases in 2009. But the history of
sleeping sickness is marked by resurgence, interspersed by decades
where the disease has seemed largely under control. In its roadmap
on neglected tropical diseases published in 2012 and supported the
same year by the London Declaration, the WHO included sleeping
sickness, and targets its elimination as a public health problem by
2020.
About
DNDi
A not-for-profit research and
development organization, DNDi works to
deliver new treatments for neglected diseases, in particular human
African trypanosomiasis, leishmaniasis, Chagas disease, filarial
infections, mycetoma, paediatric HIV, and hepatitis C. Since its
creation in 2003, DNDi has delivered eight
treatments. Fexinidazole is the first new chemical entity to be
successfully developed by DNDi.
DNDi's fexinidazole programme is
supported by grants from the Bill & Melinda Gates Foundation,
USA; UK aid, UK; Dutch Ministry of Foreign Affairs (DGIS), The
Netherlands; Federal Ministry of Education and Research (BMBF)
through KfW, Germany; French Development Agency (AFD), France;
German Corporation for International Cooperation (GIZ) on behalf of
the Federal Republic of Germany, Germany; Ministry of European and
Foreign Affairs (MEAE), France; Médecins sans Frontières; Norwegian
Agency for Development Cooperation (Norad), Norwegian Ministry of
Foreign Affairs, as part of Norway's in-kind contribution to
EDCTP2; Republic and Canton of Geneva, International Solidarity
Office, Switzerland; Spanish Agency for International Development
and Cooperation (AECID), Spain; Swiss Agency for Development and
Cooperation (SDC), Switzerland; UBS Optimus Foundation,
Switzerland; Brian Mercer Charitable Trust, UK; Stavros Niarchos
Foundation, USA and other private foundations and individuals from
the HAT campaign.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We prevent illness with vaccines, provide innovative
treatments to fight pain and ease suffering. We stand by the few
who suffer from rare diseases and the millions with long-term
chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
|
Media Relations Contact Anna
Robinson
Tel.: +33 (0)1 53 77 46 46
mr@sanofi.com
DNDi Media Relations
Contact Ilan Moss
Tel.: +1 646 266 5216
imoss@dndi.org |
Investor Relations Contact George
Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
Moyette Gibbons
Tel.: +41 79 940 9017
mgibbons@dndi.org |
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