E-drug: WHO Seeks US Approval For Anti-Malaria Drug
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WASHINGTON (Reuters) Jul 10 - The World Health Organization on Wednesday
will present its case for US approval of a malaria drug that may save the
lives of patients around the world who now lack access to emergency
treatment.
The WHO is seeking US Food and Drug Administration approval for a rectal
formulation of artesunate, which may help people who are too far from a
hospital or clinic to get injectable drugs, and who are too sick to take
oral medications.
"We saw a public health need....If we could develop a drug that would
substitute for an injectable, this would reduce the mortality that often
arises," WHO researcher Dr. Melba Gomes said in an interview.
"No company appeared to be wanting to do this," Dr. Gomes added. "There is
not a great deal of money to be made from malaria drug development."
The WHO is in talks with a small Danish company that may produce the rectal
formulation, Dr. Gomes said.
Clearance from the FDA and other regulators known for high standards would
make it easier to win approval for the drug in developing nations, Dr. Gomes
said. The WHO aims to work initially on making the drug available in a
handful of countries where disease prevalence is highest.
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