Artesunate Now First-Line Treatment for Severe Malaria in US

Megan Brooks

March 28, 2019

Starting next month, intravenous (IV) artesunate will be the first-line treatment for severe malaria in the United States, the US Centers for Disease Control and Prevention (CDC) has announced.

The change in treatment protocol stems from the fact that quinidine, the only FDA-approved IV antimalarial drug in the US, has been discontinued by the manufacturer and will no longer be available. 

Artesunate is recommended by the World Health Organization (WHO) but has not been approved by the US Food and Drug Administration (FDA).

"While at this time, artesunate is neither FDA-approved nor commercially available in the United States, CDC has taken action to ensure IV artesunate is available through an expanded use investigational new drug (IND) protocol, an FDA regulatory mechanism," the CDC said in a statement.

Starting Monday, clinicians can obtain artesunate by calling the CDC's Malaria Hotline at 770-488-7788 Monday through Friday 9 am to 5 pm Eastern time, or 770-488-7100 outside those hours.

When consultation with a CDC expert determines that IV artesunate is needed, the drug will be sent to a CDC quarantine station closest to the requesting hospital. The CDC will stock artesunate at 10 quarantine stations.

There are about 300 cases of severe malaria in the United States each year, most of them acquired from travel to countries with malaria. The CDC anticipates that there will be sufficient supply of IV artesunate for treatment of all cases of severe malaria in the US. Worldwide, malaria caused an estimated 435,000 deaths in 2017, according to the CDC.

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. In the first trimester of pregnancy, the benefits of IV artesunate outweigh the risk of death and poor outcomes due to severe malaria, the CDC said.

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