FDA Approves Artesunate, Only Drug to Treat Severe Malaria

The U.S. Food and Drug Administration approved artesunate for injection to treat severe malaria in adult and pediatric patients, first treatment for such disease available in the country since the marketing of quinidine was discontinued by its manufacturer in March 2019.

• Before the approval, IV 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 the medication to patients with severe malaria and those with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol
• According to the CDC, about ...