The US Food and Drug Administration has approved Coartem tablets (artemether and lumefantrine) for the treatment of acute, uncomplicated malaria infections in adults and children weighing at least five kilograms (approximately 11 pounds).
‘Malaria is a global life-threatening disease,’ said Murray M. Lumpkin, M.D., 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 nor to prevent malaria. Severe malaria is different than acute, uncomplicated malaria in that patients with severe malaria have altered consciousness and other metabolic and end-organ complications. These patients are not candidates for oral drugs and should be given intravenous anti-malarial therapy.
Malaria is a serious public health problem in many parts of the world. Persons from the United States who live in or travel to high-incidence areas are at risk of infection. Malaria is transmitted when a person is bitten by an infected mosquito. Coartem has been shown to be effective in geographical regions with reported resistance to chloroquine, a drug that prevents and treats malaria.
‘Because of concerns about drug resistance with currently available drug therapy, it will benefit patients to have another treatment option for malaria available,’ said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Release Date: April 8, 2009
Filed Under: Drug Discovery