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FDA Approves Artesunate for Severe Malaria

The indication is based on positive findings from a pair of Africa- and Asia-based randomized trials.

The US Food and Drug Administration (FDA) has approved intravenous (IV) artesunate for the treatment of severe malaria in adult and pediatric patients.

The indication is the first of its kind for patients with severe malaria in the US, making the therapy available through the FDA’s Expanded Access program—which allows the US Centers for Disease Control and Prevention (CDC) to provide IV artesunate to US patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug (IND) protocol.

This is also the first FDA-approved drug for the treatment of severe malaria since the discontinued marketing of quinidine by the manufacturer in March 2019.

The strength of Amivas’ application for artesunate was based on findings from an Asia-based and Africa-based randomized controlled trials.

In the Asia trial, 1461 patients were randomized to either IV artesunate or quinine. The trial included 202 pediatric patients <15 years old. In the Africa trial, 5425 pediatric patients were randomized to either therapy.

In both trials, the total number of patients treated with artesunate who died in the hospital was significantly lower than those who died in the control group.

Artesunate-treated patients reported common adverse events including acute renal failure requiring dialysis, hemoglobinuria, and jaundice.

The CDC approximates that 2000 US cases of malaria are diagnosed annually, with 300 cases being considered severe. The mostly travel-based parasitic infection drives fever, chills, and a flu-like illness in patients—and leaving it untreated can lead to kidney failure, seizures, mental confusion, and even death.

As such, the artesunate approval gives patients greater access to a “lifesaving drug,” explained John Farley, MD, acting director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

"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,” Farley said in a statement.