EMA gives positive opinion to Fexinidazole
Winthrop as first oral treatment of acute form of sleeping sickness
(rhodesiense) found in East and Southern Africa
Paris, Geneva and Nairobi. December 15,
2023. Sanofi, DNDi and the HAT-r-ACC consortium announce
the European Medicines Agency’s (EMA) Committee for Medicinal
Products for Human Use (CHMP) has adopted a positive scientific
opinion of Fexinidazole Winthrop as first oral treatment of acute
form of sleeping sickness (rhodesiense). This positive opinion is
for the treatment in adults and children six years of age or older
and weighing at least 20 kg, of both first-stage (haemo-lymphatic)
and second-stage (meningo-encephalitic) Trypanosoma brucei (T.b.)
rhodesiense sleeping sickness, an acute and lethal form of this
parasitic disease found in Eastern and Southern Africa.
This CHMP opinion follows an application by
Sanofi under Article 58 and clinical trials in Malawi and Uganda
led by the non-profit medical research organization Drugs for
Neglected Diseases initiative (DNDi). The CHMP first adopted in
2018, a positive opinion of Fexinidazole Winthrop as the first
all-oral treatment , in adults and children six years of age or
older and weighing at least 20 kg, of both first-stage
(haemo-lymphatic) and second-stage (meningo-encephalitic) of the
more common T.b. gambiense form of sleeping sickness found in West
and Central Africa.
Sleeping sickness, or human African
trypanosomiasis (HAT), is usually fatal without treatment. Both
forms of sleeping sickness are transmitted by the bite of infected
tsetse flies, which are found in 36 African countries. It causes
neuropsychiatric symptoms, including aggressiveness, psychosis, a
debilitating disruption of sleep patterns that have given this
neglected disease its name, and ultimately, death.
Dietmar Berger, MD, PhDHead of
Development and Chief Medical Officer, Sanofi“The CHMP’s positive
opinion is another step forward in Sanofi’s commitment to help
deliver innovative treatments to vulnerable patient communities
impacted by sleeping sickness, a deadly neglected tropical disease.
By working with WHO and DNDi, we have made tremendous progress in
improving treatment outcomes and simplifying treatment delivery.
This partnership and our donation of Fexinidazole Winthrop through
Foundation S, reflect our mission to provide innovative treatments
to patients, no matter where they live.”
For the T.b. rhodesiense variant, Fexinidazole
Winthrop is indicated as a 10-day, once-daily oral treatment. Data
from DNDi’s Phase 2/3 clinical trial were recently presented at the
European Congress of Tropical Medicine and International Health and
showed that Fexinidazole Winthrop was highly effective in treating
the T.b. rhodesiense form of sleeping sickness and is a safe
alternative to the existing drugs. In periodic follow-up
evaluations that continued for 12 months after treatment, only one
patient (2.94%) with the advanced form of the disease had relapsed
and required treatment with the arsenic derivative that is the
standard of care for patients with the most severe stage of the
disease.
Dr Westain NyirendaPrincipal
Investigator and physician at Rumphi Hospital in Malawi“T.b.
rhodesiense sleeping sickness is a terrifying disease that
progresses more rapidly than T.b. gambiense, killing quickly if
untreated. Until now, due to the lack of innovation for this strain
of sleeping sickness, old and toxic treatment options have to be
administered in a hospital under strict surveillance. Having a
simple and safer oral pill to treat this frightening disease will
allow doctors to rapidly save lives. It will also help patients to
trust the new treatment.”
While humans are the main host of T.b.
gambiense, T.b. rhodesiense is a zoonotic disease, meaning that the
infection can spread from animals to humans. Cattle and wild
animals such as bushbucks and zebras are the most common reservoirs
for this disease. Movements of these animals – potentially sparked
by droughts or changes in climate – could put new populations at
risk of T.b. rhodesiense sleeping sickness. In some cases, tourists
visiting game reserves have been infected with T.b.
rhodesiense.
Dr Olaf Valverde MordtClinical
Project Leader for sleeping sickness, DNDi“We are already seeing
how an all-oral treatment for T.b. gambiense sleeping sickness has
simplified the treatment of this variant in countries like the
Democratic Republic of Congo. Although there are comparatively few
cases of T.b. rhodesiense, last year Ethiopia recorded its first
cases since the 1970s. The drought at the time of the infections
brought humans and cattle in closer proximity to tsetse flies’
habitat. Environmental changes could be one of the reasons behind
this resurgence.”
The CHMP opinion today paves the way for the
update of WHO guidelines on treatment for sleeping sickness, and
distribution by WHO of Fexinidazole Winthrop in African countries
where T.b. rhodesiense is prevalent. Fexinidazole Winthrop will be
donated to WHO by Foundation S, Sanofi’s philanthropic
organization.
Dr Ibrahima Socé FallDirector
of Neglected Tropical Diseases, World Health Organization “The
impact of climate change extends to the shifting geographical
spread of vector-borne diseases such as sleeping sickness,
heightening the likelihood of spillover events where diseases
transfer from animals to humans. These shifts disproportionately
affect the most vulnerable communities, underscoring the urgency of
sustained investment in programs addressing NTDs. This includes the
development of innovative tools and improved treatment methods. We
extend our gratitude to our partners DNDi for their research for
the most neglected and Sanofi for their ongoing support and
contribution to these vital efforts.”
Fexinidazole Winthrop has already been
registered in the Democratic Republic of the Congo and Uganda as a
treatment for T.b. gambiense and is recommended for use in a
further 10 African countries: (Angola, Burkina Faso, Central
African Republic, Chad, Congo, Côte d'Ivoire, Equatorial Guinea,
Gabon, Guinea, and South Sudan).
Dr Michelle HelinskiSenior
Project Officer for Neglected Infectious Diseases at the European
and Developing Countries Clinical Trials Partnership Association
(EDCTP) “We congratulate the HAT-r-ACC consortium on developing a
better treatment option for this truly neglected disease and are
thrilled with the positive opinion by CHMP.”
The DNDi clinical trial for T.b. rhodesiense was
conducted by the HAT-r-ACC Consortium, with funding from the
European and Developing Countries Clinical Trials Partnership
Association (EDCTP2) programme supported by the European Union;
Fundação para a Ciência e a Tecnologia from Portugal; Swiss Agency
for Development and Cooperation (SDC), from Switzerland; Médecins
Sans Frontières International; and UK International Development,
United Kingdom; and other private foundations and individuals.
About SanofiWe are an innovative global
healthcare company, driven by one purpose: we chase the miracles of
science to improve people’s lives. Our team, across some 100
countries, is dedicated to transforming the practice of medicine by
working to turn the impossible into the possible. We provide
potentially life-changing treatment options and life-saving vaccine
protection to millions of people globally, while putting
sustainability and social responsibility at the center of our
ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
About DNDiThe Drugs for Neglected Diseases
initiative (DNDi) is a not-for-profit medical research organization
that discovers, develops, and delivers safe, effective, and
affordable treatments for neglected people. DNDi is developing
medicines for sleeping sickness, leishmaniasis, Chagas disease,
river blindness, mycetoma, dengue, paediatric HIV, advanced HIV
disease, cryptococcal meningitis, and hepatitis C. Its research
priorities include children’s health, gender equity and
gender-responsive R&D, and diseases impacted by climate change.
Since its creation in 2003, DNDi has joined with public and private
partners across the globe to deliver twelve new treatments, saving
millions of lives. dndi.org
About HAT-r-ACCThe HAT-r-ACC consortium brings
together a broad range of partners with expertise in sleeping
sickness and capacity building in remote health settings. This
research, training, and community engagement experience is
essential to run the clinical trial in remote settings with a very
small target population. The consortium partners include the Malawi
Ministry of Health (MMoH), the Uganda National Health Research
Organisation (UNHRO), the Makerere University in Uganda, Epicentre
(MSF) in France, the Lisbon Institute of Hygiene and Tropical
medicine (IHMT) in Portugal, the Institut de Recherche pour le
Développement (IRD) in France, the WHO, and the Swiss Tropical and
Public Health Institute (Swiss TPH).
Sanofi Media RelationsSandrine
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| nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.com
Sanofi Investor RelationsEva
Schaefer-Jansen | + 33 7 86 80 56 39
| eva.schaefer-jansen@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comCorentine
Driancourt | + 33 6 40 56 92 21 |
corentine.driancourt@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comTarik Elgoutni| + 1 617
710 3587 | tarik.elgoutni@sanofi.comNathalie
Pham | + 33 7 85 93 30 17 |
nathalie.pham@sanofi.com
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Ojardias in Geneva | +41 79 431 62 16
| fojardias@dndi.org
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