Medical experts back Novartis’ malaria drug as safe, effective

ROCKVILLE, Md. A Novartis drug for treating malaria is safe and effective, a panel of medical experts hired by the Food and Drug Administration said Wednesday.

By voting almost unanimously in favor of the conclusion that Coartem (artemether-lumefantrine) is safe and effective, the panel effectively recommended its approval in the United States. It already has approval in more than 80 other countries. The FDA gave the drug priority review in September, according to Novartis.

Novartis hopes the FDA will approve it to treat the deadliest form of malaria, a mosquito-borne illness common in developing countries in the tropics. It is a combination of two existing malaria drugs.