IV artesunate is the only drug available in the U.S. to treat the disease.
FDA cleared the only drug in the U.S. to treat severe malaria in adults and children. There has been no FDA-approved drug to treat severe malaria since the marketing of quinine was discontinued by the manufacturer in March 2019, the agency said in a press release.
FDA okayed IV artesunate (Amivas), which should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Previously, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the 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.
“This approval will now give patients more access to a lifesaving drug,” said 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.”
According to the CDC, approximately 2,000 cases of malaria are diagnosed in the U.S. each year, and around 300 of those infected have severe disease. Most people diagnosed with malaria in the United States acquire it during travel to countries with malaria.
The safety and efficacy of IV artesunate was primarily evaluated in a randomized controlled trial in Asia (Trial 1) and a supportive published randomized controlled trial in Africa (Trial 2).
In both trials, the number of patients treated with artesunate who died in the hospital was significantly lower than the number who died in the control group treated with quinine.
In Trial 1, the most common adverse reactions in patients with malaria treated with IV artesunate were acute renal failure requiring dialysis, hemoglobinuria and jaundice. The safety profile in Trial 2 was generally similar to Trial 1.