Availability of Intravenous Artesunate for Treatment of Severe Malaria in the United States

There are approximately 300 cases of severe malaria in the United States each year, most of them acquired from travel to countries with malaria. Severe malaria should be treated with intravenous (IV) antimalarial medications. The only U.S. Food and Drug Administration (FDA)-approved IV antimalarial in the United States, IV quinidine, has been discontinued, and is no longer available. CDC is providing IV artesunate for the treatment of severe malaria.

IV artesunate is the first-line, WHO-recommended treatment for severe malaria but is neither FDA-approved nor commercially available in the United States. It is unknown when IV artesunate will be FDA approved, as the approval process requires a drug company to submit a new drug application to FDA. The Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Materiel Development Activity have worked together to develop IV artesunate for the United States.

Since 2007, CDC has made IV artesunate, supplied by the U.S. Army Medical Research and Materiel Command (USAMRMC), available under an expanded access investigational new drug (IND) protocol in cases where quinidine is not available, not tolerated, or not working. With the discontinuation of IV quinidine, IV artesunate is now the first-line drug for treatment of severe malaria in the United States.

Clinicians treating patients with severe malaria should call CDC to obtain IV artesunate. The CDC Malaria Hotline (770-488-7788) is available Monday–Friday, 9am–5pm, Eastern time. Outside these hours, providers should call 770-488-7100 and ask to speak with a CDC Malaria Branch expert.

IV artesunate is prepositioned throughout the United States and sent free of charge to the major airport closest to the requesting hospital. We anticipate that hospitals can expect timely delivery of IV artesunate, but delivery times will vary depending on the requesting hospital’s proximity to one of the storage sites. Since severe malaria can progress rapidly, CDC has guidance on interim treatment while waiting for IV artesunate to arrive.

Page last reviewed: March 27, 2019