Posted by Michael Wonder on 27 May 2020
FDA approves only drug in U.S. to treat severe malaria
26 May 2020 - Today, the U.S. FDA approved artesunate for injection to treat severe malaria in adult and paediatric patients.
Treatment of severe malaria with intravenous artesunate should always be followed by a complete treatment course of an appropriate oral anti-malarial regimen.
Prior to this approval, intravenous artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the U.S. Centers for Disease Control and Prevention to provide intravenous artesunate to U.S. patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug protocol. There has been no FDA approved drug for treatment of severe malaria in the United States since the marketing of quinidine was discontinued by the manufacturer in March 2019.
