The Food and Drug Administration (FDA) is poised to decide by Friday whether to green-light the use of the malaria drug Coartem as part of an expedited review reserved for life-saving treatments that the agency believes are more effective than existing therapies. An FDA advisory panel earlier this month overwhelmingly determined the drug to be safe and effective; the agency is not bound by recommendations but typically follows them.

Coartem, derived from the Chinese herb artemisinin, wipes out malaria in more than 96 percent of patients in regions where malaria has become resistant to older drugs, according to drug-maker Novartis. Traditional meds such as chloroquine work in only 50 percent of patients where the parasite is drug-resistant. There were an estimated 247 million malaria cases in 2006, and nearly 881,000 patients died, according to the World Health Organization.

Only around 1,500 people in the United States — mostly travelers returning from abroad or service members stationed in malaria hot spots — are diagnosed with the infection annually. But disease specialists said travelers might carry Coartem in case they contracted malaria — and bypass preventive meds such as Lariam, which can have psychological effects.

A Novartis spokesman said the company would release pricing information if Coartem receives FDA approval. We asked journalist Merrill Goozner, director of the Integrity in Science Project at the Center for Science in the Public Interest in Washington, D.C., who has covered the development of Coartem and written for ScientificAmerican.com on multi-drug resistant tuberculosis in Siberia, to tell us a bit more about it. Below is an edited transcript of our chat.

What is coartem?

It is a combination drug of two ingredients, neither of which has been approved in the U.S. One is artemether, a chemical derivative of artemisinin, an extract from the sweet wormwood bush that was used in Chinese medicine as a fever cure for 500 or 600 years. Artemether stays in the body for three days. The other is lumefantrine, a broad-spectrum antibiotic that stays in the body for about seven days. Coartem is the most effective treatment for Plasmodium falciparum malaria, the more lethal form.

Artemether is a very potent, but fast-clearing drug, which is why you take both it and lumefantrine. Malaria has a whole life cycle in the body; there can be slow-emerging parasites that can come out of the liver after three days, which is why it's good to have the lumefantrine around a little longer. If anything should reemerge after three days, the lumefantrine will combat it.

Tell us a little bit about Coartem's history.

Coartem was approved by the Swiss in the late 1990s and put on the World Health Organization (WHO) essential drug list in 2002, so it's not a new drug by any stretch of the imagination.

It's a combination pill. In a third-world setting where Coartem is primarily used, this is very convenient because it increases compliance.

It is the preferred treatment for falciparum malaria because many strains are resistant to choloroquine. As the strain developed resistance, there was a horrible need for new drugs, and this drug met it.

What would FDA approval do for Americans with malaria?

This is a drug of no consequence in the U.S. Artemether is available in intravenous form. If you were a hospital where a soldier were returning who had cerebral malaria, which is life-threatening, you could make a call to the Centers for Disease Control and tap its supply chain.

[The Tropical Disease Priority Review Voucher law, which took effect this fall, allows drug companies that develop treatments for neglected diseases like malaria an expedited review by the FDA. That means that in the future, Novartis can bring another, more lucrative drug candidate before the agency for quicker approval — or sell that right for hundreds of millions of dollars, Goozner says. “Yes, well, this is a gift from heaven,” Silvio Gabriel, who manages Novartis' malaria initiatives, told today's New York Times.]

 

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