FDA Approval of Artesunate for Injection in Treating Severe Malaria

Artesunate for injection will be manufactured and distributed by Amivas (US), LLC, a company formed for making this drug readily available in the U.S.

Intravenous (IV) artesunate is recommended for initial treatment of severe malaria in adults and children but in the U.S. has been available only through an expanded-access investigational new drug (IND) program managed by the CDC. On May 26, 2020, the FDA announced approval of artesunate for injection to treat severe malaria in adults and children.

With discontinuation of IV quinidine in the U.S. in early 2019, IV artesunate became the first-line treatment for severe malaria and the only effective parenteral therapy available to U.S. clinicians. Of about 2000 U.S. cases of malaria each year, about 300 are severe and can be fatal without prompt treatment.

With the approval, Amivas can manufacture artesunate for injection and will set up a nat…

Author

Mary E. Wilson, MD

Disclosures

Consultant/Advisory BoardOneHealthTrust (formerly Center for Disease Dynamics, Economics, and Policy); Global Health Institute, University of Wisconsin

RoyaltiesUpToDate

Editorial BoardsJournal of Travel Medicine

Mary E. Wilson, MD

Disclosures

Consultant/Advisory BoardOneHealthTrust (formerly Center for Disease Dynamics, Economics, and Policy); Global Health Institute, University of Wisconsin

RoyaltiesUpToDate

Editorial BoardsJournal of Travel Medicine

FDA Approval of Artesunate for Injection in Treating Severe Malaria

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