FDA approved artesunate for injection to treat severe malaria in adult and pediatric patients. Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Prior to this 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 (CDC) to provide IV 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 (IND) protocol. There has been no FDA-approved drug for treatment of severe malaria in the United States since the marketing of quinine was discontinued by the manufacturer in March 2019.
The FDA granted this application Priority Review designation, under which the FDA’s goal is to take action on an application within an expedited time frame and Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted approval of artesunate for injection to Amivas.
According to the CDC, approximately 2,000 cases of malaria are diagnosed in the United States each year, with 300 of those infected having severe disease. Most people diagnosed with malaria in the United States acquire it during travel to countries with malaria.