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Novartis malaria drug approved in US

The FDA has approved Novartis' Coartem tablets for the treatment of acute, uncomplicated malaria infections

The US Food and Drug Administration (FDA) has approved Novartis' Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least 5kg.  

"Malaria is a global life-threatening disease," said Murray M Lumpkin, deputy commissioner for International and Special Programs, FDA. "It is encouraging to have new treatment available, particularly for children."

Coartem is not approved for the treatment of severe malaria or to prevent malaria. Severe malaria patients are not candidates for oral drugs.

Coartem has been shown to be effective in geographical regions with resistance to chloroquine, a drug that prevents and treats malaria.

About 90 per cent of malaria deaths occur in Sub-Saharan Africa, but the disease is also prevalent in parts of Asia and Latin America. It is estimated that 350 to 500 million new cases develop worldwide annually and 1 million patients, primarily young children, die of the disease.

Artemether, one of the active ingredients in Coartem tablets, is the first artemesinin class drug approved in the US. The artemesinins are derived from the leaves of the Artemisia annua plant that are used to treat malaria.

In compliance with a provision of the FDA Amendments Act of 2007, the FDA awarded Novartis a priority review voucher to use towards a future new drug application. The provision, designed to encourage development of drugs to treat tropical diseases, authorises the granting of such vouchers to sponsors of treatments for certain tropical diseases. 

15th April 2009

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