(Updates with additional information from panel meeting)
By Jennifer Corbett Dooren Of DOW JONES NEWSWIRES WASHINGTON -(Dow Jones)- A Food and Drug Administration panel said clinical studies showed a Novartis AG (NVS) malaria drug was safe and effective at treating one type of the mosquito-borne illness.
The drug, Coartem, already approved for use in more than 80 countries, was reviewed by an FDA panel of outside medical experts Wednesday.
The panel voted 18 to 0 in favor of a question that asked whether clinical data submitted showed whether the drug worked, and 17 to 1 in favor of a question that asked if the data showed the drug was safe.
The panel votes amount to a recommendation that the FDA approve the drug. Some panel members, however, said they were concerned about small amounts of data on young children and the elderly, and were also concerned about interactions with other drugs given to travelers to prevent malaria, as well as birth control pills and HIV drugs.
The drug is a combination of two ingredients designed to treat malaria, which is caused by four types of parasites and spread by mosquitoes. Novartis is seeking FDA approval for Coartem to treat malaria infections caused by the parasite P falciparam, which causes the most deadly form of the illness.
While malaria is rare in the U.S., illnesses from P falciparam affect more than 200 million people globally each year and cause about 1 million deaths, according to World Health Organization figures. About 1,500 infections are reported in the U.S., but some are resistant to currently approved treatments.
The panel said malaria infections caused by another parasite, such as P. vivax, or people with so-called mixed infections caused by more than one parasite, need to also be treated with another drug - a fact that needs to be spelled out on Coartem's label. The panel also said more data is needed from post-marketing studies looking at the drug in babies, pregnant women and nursing mothers, among other groups.
If approved, Coartem would be the first so-called artemisinin-based combination therapy, or ACT, for malaria on the U.S. market. The drug would be given twice a day for three days.
The FDA has granted Coartem priority review, which is typically reserved for life-saving treatments the agency thinks are an advance over current therapies. Priority review also results in a six-month review of a drug application rather than the standard 10-month review.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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(END) Dow Jones Newswires
December 03, 2008 16:04 ET (21:04 GMT)

Publié le 03 Décembre 2008 Copyright © 2008 Dowjones