Although it is not FDA approved, artesunate will become the first-line treatment for severe malaria in the United States starting on April 1, according to new clinical guidance issued today by the CDC.
“This change in treatment protocol is necessary because the only FDA-approved intravenous (IV) antimalarial drug in the U.S., quinidine, has been discontinued by the manufacturer and will no longer be available,” the CDC explained.
Eli Lilly previously announced in December 2017 that it would stop making quinidine but would continue to distribute it until the label expired in March of this year.
Artesunate is already recommended by WHO as the first-line treatment for severe malaria, but the drug has been available only for certain patients in the U.S. and still must be obtained through the CDC, which makes it available under an FDA expanded use or investigational new drug protocol.
There are about 300 cases of severe malaria diagnosed in the U.S. each year, most of them in patients who were infected during travel to other countries, according to the CDC.
“Clinical studies have shown that IV artesunate is safe, well tolerated and can be administered to infants and children, and to pregnant women in their second and third trimesters and during lactation,” the agency said. “In the first trimester of pregnancy, the benefits of IV artesunate treatment outweigh the risk 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 consultation with a CDC expert determines that IV artesunate is needed, the drug will be released free of charge to the CDC quarantine station nearest to the requesting hospital,” the CDC noted. “While hospitals are responsible for the pickup arrangements, CDC is stocking artesunate at 10 quarantine stations and will work with the stations and hospitals to ensure swift receipt of the treatment. CDC anticipates that there will be sufficient supply of IV artesunate for treatment of all cases of severe malaria in the U.S.” – by Gerard Gallagher