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Although it is not approved by the FDA, artesunate will become the first-line treatment for severe malaria in the United States as of April 1, according to new clinical guidelines published today by the CDC.
"This change of treatment protocol is necessary because the only FDA-approved intravenous antimalarial drug, quinidine, has been stopped by the manufacturer and will no longer be available," the CDC said.
In December 2017, Eli Lilly had already announced its intention to cease the manufacture of quinidine, but continue to distribute it until the expiration of the label, in March this year.
WHO is already recommending artesunate as a first-line treatment for severe malaria, but the drug is only available for certain patients in the United States and should always be obtained through the CDC, making it available as part of the an expanded use of the FDA or new drug protocol studies.
According to the CDC, approximately 300 cases of severe malaria are diagnosed each year in the United States, most of them in infected patients while traveling to other countries.
"Clinical studies have shown that artesunate IV is safe, well tolerated and can be administered to infants and children, as well as to pregnant women during the second and third trimesters and during badfeeding. "said the agency. "During the first trimester of pregnancy, the benefits of intravenous artesunate treatment outweigh the risks of death and poor outcomes due to severe malaria."
Starting April 1, clinicians can call the CDC Malaria Hotline at 1-770-488-7788 to obtain IV artesunate.
"When consulting with a CDC expert will determine that artesunate IV is needed, the drug will be distributed free to the CDC quarantine center closest to the requesting hospital," the CDC said. "While hospitals are responsible for pickup arrangements, the CDC stores artesunate at 10 quarantine stations and will work with stations and hospitals to ensure timely receipt of treatment. DCC anticipates that there will be an adequate supply of artesunate IV for the treatment of all cases of severe malaria in the United States "- by Gérard Gallagher
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