By MATTHEW PERRONE
AP Business Writer
WASHINGTON (AP) _ Federal regulators said Monday a combination drug from Novartis to treat malaria works better than older drugs already on the market.
The Swiss drugmaker has asked the Food and Drug Administration to approve its Coartem pill for malaria, including the most virulent strains of the disease. The drug is already used in 83 countries worldwide.
The
FDA posted its review of Coartem online ahead of a panel meeting Wednesday, where outside advisers will weigh in on the drug's safety and effectiveness.
Malaria is caused by microscopic parasites spread by mosquitoes and causes extreme pain, fever and sometimes death. The disease kills about 1 million people a year, with most deaths occurring in sub-Saharan Africa, according to the World Health Organization.
Malaria, which is both preventable and treatable, has been all but eradicated in wealthy nations. Only about 1,500 cases are reported in the U.S. annually, according to the Centers for Disease Control. But as much as 40 percent of the world's population is at risk, mostly in the poorest countries. Drug resistance also has been a major hurdle in the treatment of malaria, according to documents posted online by Novartis.
Agency reviewers said that Coartem, which combines two older malaria drugs, appeared to work better than its separate components. Studies conducted by Novartis in Asia showed roughly 90 percent of patients were cured 28 days after receiving treatment. The cure rate in European travelers was slightly lower at 74 percent, but FDA said that might be because some were not tracked for the full month and were counted as failures.
Coartem is taken in six doses administered over three days.
FDA scientists said a review of more than 3,400 trial patients showed few deaths or serious side effects with the drug. The most common side effects reported included headache, dizziness and loss of strength, which were likely related to malaria.
According to its draft questions, FDA said it would ask its panel of infectious-disease experts whether Novartis' drug appears safe and effective. Panelists also will be asked to recommend any safety labeling that should accompany the drug.
The FDA is not required to follow the group's advice, though it usually does.