CDC has announced that it will make intravenous artesunate available for the treatment of severe malaria once quinidine is no longer available beginning April 1, 2019. Production of quinidine, the drug currently used for treatment of severe malaria in the United States, has been discontinued.
“Artesunate is the best treatment for severe malaria,” said ASTMH President Chandy C. John, MD, MS, FASTMH, “and making it the first-line therapy is a big advance for malaria treatment in the United States. We thank the CDC, the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity for their efforts to make this treatment available. We’re looking forward to their update on how clinicians will be able to rapidly obtain artesunate for their patients with severe malaria, and what treatment they should provide while waiting to receive artesunate. The answers to these important questions will be critical in ensuring the best care for patients with severe malaria.”
Starting April 1, 2019, 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. Guidance on how to administer artesunate will be released before April 1, 2019.
Artesunate is the first-line, WHO-recommended treatment for severe malaria but is neither FDA-approved nor commercially available in the United States, CDC said in a statement. 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. 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 will become the first-line drug for treatment of severe malaria in the United States. To address this increased demand, CDC has imported additional IV artesunate for distribution under an IND protocol. CDC and USAMRMC are working to ensure the availability of IV artesunate for all cases of severe malaria in the United States.
More information, including an FAQ, is available here on the CDC website.