WASHINGTON, Dec 1 (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.
(Reporting by Susan Heavey, editing by Gerald E. McCormick)
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