Only drug in US to treat 'severe' malaria approved by FDA, federal agency says

The Food and Drug Administration (FDA) this week announced the approval of the only drug in the country to treat “severe” cases of malaria in both adults and pediatric patients.

The FDA granted approval for the drug, artesunate, for injection, to the Maryland-based company Amivas, according to a Tuesday statement on the federal agency’s website. 

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“Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen,” the FDA said when announcing its approval.

“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,” the FDA said, noting that in the U.S., there has been “no FDA-approved drug for treatment of severe malaria… since the marketing of quinine was discontinued by the manufacturer in March 2019.”

In two separate randomized control trials, the drug was found to lower the death rate in those treated with it when compared to patients treated with quinine, the FDA said.

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“This approval will now give patients more access to a life-saving drug,” said Dr. John Farley, the acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a statement. “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.”

Each year, the U.S. sees about 2,000 cases of malaria, with 300 of those cases considered severe, as per the FDA.