The US Food and Drug Administration has approved Coartem (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilogrammes due to plasmodium falciparum, the most dangerous form of the disease. The approval was expected after an FDA advisory panel declared the treatment to be safe and effective in December.
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said that because of concerns about resistance with currently available therapy, “it will benefit patients to have another treatment option for malaria”. Novartis says that Coartem is a highly-effective three-day therapy with cure rates of over 96%, “even in areas of multi-drug resistance”.
Novartis chief executive Daniel Vasella said that with a growing number of malaria cases in the USA due to rising travel, it is important to make artemisinin-based combination treatment such as Coartem, the most effective therapy for malaria, available to American patients as well."
Fighting malaria “is very much in America's interest and ACTs such as Coartem are important weapons against this infectious disease," said Tim Ziemer, the US government’s malaria coordinator. The Swiss major, which noted that it supplies Coartem for public sector use in Africa without profit, has to date provided more than 235 million treatments, which have helped save an estimated 600,000 lives, mostly children.
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