FDA Approves Severe Malaria Treatment

The US Food and Drug Administration (FDA) has approved intravenous artesunate for the treatment of severe malaria among adults and children. Prior to this approval, this drug was only available through the FDA’s Expanded Access program.

“This approval will now give patients more access to a lifesaving drug,” said John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release. “Furthermore, the risk of developing severe malaria emphasizes the importance of taking medications to prevent malaria and using mosquito avoidance measures when traveling to malaria-endemic areas,” he added.

The FDA notes that a complete treatment course of an appropriate oral antimalarial regimen should always follow the use of intravenous artesunate in the treatment of severe malaria.

The most commonly reported adverse reactions among artesunate-treated patients with malaria are jaundice, acute renal failure requiring dialysis, and hemoglobinuria.

—Christina Vogt

Reference:
FDA approves only drug in U.S. to treat severe malaria. News release. US Food and Drug Administration. May 26, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-only-drug-us-treat-severe-malaria