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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Approves Coartem Tablets to Treat Malaria
The U.S. 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, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.
Symptoms of malaria include fever, chills, and flu-like illness. Left untreated, the disease can cause severe complications, including death. About 90 percent 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.
Coartem should be taken with food, particularly food that contains fat, because this allows the body to absorb the drug well.
The most common adverse reactions to Coartem shown in clinical trials in adults are headache, anorexia, dizziness, physical weakness (asthenia), joint pain (arthralgia) and muscle pain (myalgia). The most common adverse reactions reported in children are fever (pyrexia), cough, vomiting, loss of appetite, and headache.
Artemether, one of the active ingredients in Coartem tablets, is the first artemesinin class drug approved in the United States. 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 Food and Drug Administration Amendments Act of 2007, the FDA awarded Novartis a one-time priority review voucher to use towards a future new drug application. The provision, which was designed to encourage development of drugs to treat tropical diseases, authorizes the granting of such vouchers to sponsors of treatments for certain tropical diseases. The voucher may be transferred by the recipient to another manufacturer.
Coartem is made by Novartis Pharmaceuticals Corporation, Basel, Switzerland.
For additional information, see:
Draft Guidance for Industry: Tropical Disease Priority Review Vouchers
FDA Anti-Infective Drugs Advisory Committee