FDA Approves First-Line Drug for Severe Malaria

By Kristin J. Kelley

Edited by Susan Sadoughi, MD, and Richard Saitz, MD, MPH, FACP, DFASAM

Intravenous artesunate has been approved by the FDA to treat severe malaria in both adults and children. After treatment is complete, patients need to take a course of an oral antimalarial.

IV artesunate is the only drug approved for severe malaria in the U.S., as quinidine was discontinued in early 2019. Before now, it was available only via the FDA's expanded access program, through which the CDC could provide the drug under an investigational new drug protocol.

The most common adverse reactions seen in trials of IV artesunate include acute renal failure, hemoglobinuria, and jaundice.