FDA approves Novartis malaria drug

ROCKVILLE, Md. The Food and Drug Administration has approved a new drug to treat malaria from Novartis.

The agency announced Wednesday that it approved Novartis’ Coartem (artemether and lumefantrine) tablets for the treatment of acute, uncomplicated malaria in children and adults weighing at least 11 lbs.

“Malaria is a global, life-threatening disease,” FDA deputy commissioner for international and special programs Murray Lumpkin said. “It is encouraging to have new treatment available, especially for children.”

Coartem is not approved for treating severe malaria or for preventing malaria. Patients with severe malaria, who experienced altered consciousness and other metabolic and end-organ complications, should receive intravenous anti-malarial therapy.

Between 350 and 500 million new cases of malaria develop worldwide every year, and 1 million patients die, mostly young children. The disease is mostly prevalent in Africa, Asia and Latin America.