This drug is the first FDA-approved malaria treatment on the market since March 2019, when quinine was pulled from the market by its manufacturer. Prior to this approval, artesunate was only available 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 explained. The agency granted the drug Priority Review and Orphan Drug designations.
Treatment with IV artesunate should be followed by a treatment course of an oral antimalarial regimen, the agency added.
“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, 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.”
This approval was based on the results of a pair of randomized controlled trials — Trial 1 was conducted in Asia, while Trial 2 was conducted in Africa.
“Trial 1 enrolled 1,461 patients who received either IV artesunate or the comparator drug quinine and included 202 pediatric patients younger than 15 years,” the FDA wrote. “Trial 2 included 5,425 randomized pediatric patients younger than 15 years of age with severe malaria who were treated with artesunate or quinine. 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.”
The most common adverse reactions associated with IV artesunate were acute renal failure requiring dialysis, hemoglobinuria, and jaundice, the agency noted, adding that the drug should not be used in patients with a known serious allergy to artesunate.
Intravenous artesunate is manufactured by Amivas.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 190
Topic ID: 79,190,730,190,520,138,192