ROME, July 6 /PRNewswire/ --
- An Innovative Fixed-Dose Combination Therapy, With a Very Simple Dosing
Regimen, for Combating a Disease That Accounts for 250 Million Cases Worldwide
Per Year and Causes 880,000 Deaths, Especially of Children Under 5 in
Sigma-tau Industrie Farmaceutiche Riunite S.p.A. (sigma-tau) has announced the
submission of a centralized Marketing Authorization Application (MAA) to the
European Medicines Agency (EMEA) for Eurartesim(R)
(dihydroartemisinin/piperaquine), a novel fixed-dose Artemisinin-based
Combination Therapy or ACT. Eurartesim(R) is highly effective against
uncomplicated malaria in adults and children, has a simple dosing regimen (only
3 administrations over 3 days) and has been shown to offer greater protection
against new infections than other ACTs, for at least 2 months after treatment.
In 2008, malaria was endemic in 109 countries, 45 of which were in Africa. It
afflicts up to 250 million people worldwide every year and causes around 880,000
deaths mainly in sub-Saharan Africa, over 85% of whom are children under 5.
Currently, only a handful of antimalarials remain effective as treatment.
Eurartesim(R) will be a welcome addition to the arsenal of malaria drugs and,
once approved and marketed, it could help to save the lives of hundreds of
thousands of young African children.
This new ACT is the first product of a collaboration between sigma-tau and
Medicines for Malaria Venture (MMV), an international not-for-profit
organisation. Developed to high international standards, this new ACT meets WHO
clinical treatment recommendations, as it combines two active antimalarial
ingredients in a single tablet: the highly potent artemisinin-derivative
(dihydroartemisinin) with a second antimalarial (piperaquine) which protects the
first one against the emergence of resistance.
Eurartesim(R) has already received the Orphan Drug Designation by both European
and US regulatory authorities. After receiving approval from the EMEA, sigma-tau
also intends to consider filing for marketing authorization in the US. Stringent
regulatory approval, guarantee of highest international standards respect, is a
precondition for approval in Africa and, once this precondition is met the
dossier will be submitted to selected African countries with the support of
Pfizer, sigma-tau's partner to commercialize the drug in Africa's private sector
in order to maximize Eurartesim's potential to reach as many patients as
The MAA is supported by data from large clinical trials that involved over 2,700
patients in Africa (Burkina Faso, Zambia, Kenya, Mozambique and Uganda) and Asia
(Thailand, India and Laos). 1,600 of these were children under 5, all with
uncomplicated malaria caused by Plasmodium falciparum, the most widespread and
dangerous malaria parasite. The studies were designed to compare the safety and
efficacy of the combination of dihydroartemisinin and piperaquine (DHA/PQP) to
the ACTs artemether/lumefantrine (in Africa) and artesunate+mefloquine (in
Results from both studies show that Eurartesim(R) treats malaria as rapidly and
effectively as the other ACTs. It has also been shown to offer significant
protection from new infections in many cases for about 2 months. In addition, it
features a simple schedule: a patient weighing 60 kg needs to take a total of 9
tablets over 3 days compared to the 14 to 24 tablets with other antimalarials.
Fever and parasites disappear after only 2-3 days from start of treatment.
sigma-tau is committed to the development of new therapies that will benefit
people living with tropical diseases like malaria - said Dr. Claudio Cavazza,
President of sigma-tau - We agree with the WHO's call to pharmaceutical
companies to develop new antimalarials according to the highest international
quality standards. We make available our industrial know-how for allowing drug
distribution, at a sustainable price, in those countries where malaria still
kills unacceptable numbers of people, sharing the aim of the main industrialised
countries taking part in G8 scheduled in L'Aquila. The submission for this
innovative ACT brings us one step closer to providing a potent treatment to
vulnerable populations in malaria-endemic countries where malaria has a
tremendous health and socio-economic impact, as well as to European and American
citizens travelling to those countries for business or tourism.
The submission of Eurartesim(R) to the EMEA is a landmark event and the
culmination of several years' productive collaboration between sigma-tau and
Medicines for Malaria Venture - said Dr Chris Hentschel, President and CEO of
Medicines for Malaria Venture - Head-to-head studies carried out to
internationally approved standards have shown that this ACT is at least as safe
and efficacious as two other well-known ACTs. Its addition to the therapeutic
arsenal will give more choice to health policy makers and caregivers in
malaria-endemic countries to choose the right medicine for their patients.
SOURCE: Publicis Consultants
For more information: Press Office, Publicis Consultants Italia, Alessandro
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+39-02-7632091, Fax: +39-02-76320940