Novartis malaria drug safe, effective: FDA

By Susan Heavey

WASHINGTON (Reuters) - Data show Novartis AG’s combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday.

“The majority of AEs (adverse events) were of mild or moderate intensity. Deaths … and SAEs (serious adverse events) … were reported infrequently,” the staff wrote in documents released ahead of an FDA advisory panel meeting on Wednesday to discuss the drug.

The Swiss drugmaker is seeking FDA approval for the drug, which combines artemether and lumefantrine, to treat acute, uncomplicated malaria infections.

If approved, Coartem would be the first artemisin-based combination therapy (ACT) cleared in the United States.

While several other types of drugs are already FDA-approved to treat malaria, government experts consider ACTs most effective. Coartem has also been recommended by the World Health Organization, according to Novartis.

Malaria is spread through mosquito bites, which release parasites into the blood stream and cause flu-like symptoms such as fever, vomiting and diarrhea. The disease is mostly a problem in warm, developing countries but can be prevented with antimalarial drugs and by curbing mosquito-bites through the use of nets, bug sprays and protective clothing.

As many as 500 million cases of malaria occur each year around the world, mostly in Africa, according to the U.S. Centers for Disease Control and Prevention. Just 1,337 cases were reported in the United States in 2002.

Another type of combination drug, GlaxoSmithKline Plc’s Malarone, is also cleared for use in the United States, but “it would be beneficial to have an additional approved treatment available,” Novartis said in separate company documents also released by the FDA.

The documents are posted on the FDA’s website here

(Reporting by Susan Heavey, editing by Gerald E. McCormick, Dave Zimmerman)

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