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Published on 9 April 2009

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Coartem® receives FDA approval

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Coartem® (artemether 20mg/lumefantrine 120mg), the leading artemisinin-based combination treatment (ACT) for malaria worldwide, has been approved by the US Food and Drug Administration (FDA).

Coartem is a fixed-dose combination of two novel antimalarials. It is a highly effective three-day malaria treatment with cure rates of over 96% even in areas of multidrug resistance.

Each year millions of Americans travel to malaria-endemic regions on business or pleasure, and this has led to a rise in cases of “traveller’s malaria”. Unlike patients in more than 80 countries, including in many European nations, US patients have not had access to ACTs such as Coartem.

“Around the world, Coartem has eliminated suffering for millions and saved lives for hundreds of thousands of malaria patients,” said Dr Daniel Vasella, chairman and CEO of Novartis.

“With a growing number of malaria cases in the US due to rising travel, it is important to make ACT treatment such as Coartem, the most effective therapy for malaria, available to American patients as well.”

Each year, there are nearly one million malaria-related deaths around the world. In Africa alone, a child dies every 30 seconds from malaria. To help alleviate the tremendous problem of access to treatment, Novartis provides Coartem treatments for public sector use in Africa without profit.

To date, Novartis has provided more than 235 million Coartem treatments, which have helped save an estimated 600,000 lives – mostly children.

“Fighting malaria is very much in America’s interest, and ACTs such as Coartem are important weapons against this infectious disease,” said Rear Admiral Tim Ziemer, US Malaria Coordinator. “We welcome FDA approval of Coartem.”

In the US, Coartem will be made available through pharmacies and hospitals.

Coartem is indicated for the treatment of acute uncomplicated infections due to Plasmodium falciparum, the most dangerous form of malaria.



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