- The Sigma-Tau Pharmaceutical has announced an innovative combination therapy fixed dose to fight Malaria, the disease that is responsible for 250 million cases worldwide and causes more than 880,000 deaths, especially among children under 5 years in sub-Saharan Africa.
In 2008, malaria was endemic in 109 countries, 45 of them in Africa.
According to Sigma-Tau Pharmaceutical statement, Eurartesim is highly effective against uncomplicated malaria in adults and children and has a simpler dosing regimen of only three days in three administrations.
“It has proved to offer greater protection against new infections for at least 2 months after treatment,” it said.
The statement said currently, only a handful of anti-malaria treatment remains effective, saying the Eurartesim will be a welcome addition to the arsenal of drugs for malaria. “Once approved and marketed, could help save the lives of hundreds of thousands of African children,” the company said.
The statement said the medicine which is a product of a collaboration between Sigma-Tau and Medicines for Malaria Venture (MMV) meets the recommendations of the WHO clinical treatment because it combines two active ingredients in anti-single tablet.
“It is the highly potent derivative of artemisinin (dihydroartemisinin) with a second anti-(piperaquine) which protects the first against the emergence of resistance,” it said.
Eurartesim has already received a subsidised drug designation from the US and European regulatory authorities.
It said the regulatory approval is a precondition for the adoption in Africa, and once this precondition is met, the dossier will be submitted to selected African countries with support from Pfizer.
The trials of the new drug involved large clinical trials over 2,700 patients in African countries like Burkina Faso, Zambia, Kenya, Mozambique and Uganda. It was also conducted in other Asian countries.
It is reported that 1600 of these trials were on children under 5 years, all with uncomplicated malaria caused by Plasmodium falciparum, the malaria parasite expanded and more dangerous.
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