The U.S. Food and Drug Administration (FDA) has approved intravenous (IV) artesunate to treat patients with severe malaria. The treatment should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.
Until now, IV artesunate was only available to patients through the FDA’s Expanded Access program.
In the U.S., approximately 300 people each year develop severe malaria. At least, in most years. The majority of severe malaria cases in the U.S. occur in persons travelling back from sub-Sarahan Africa and South Asia where the parasite thrives. This year, it is unlikely that many U.S. citizens will develop severe malaria.
Malaria is a parasitic disease transmitted by a mosquito bite. Symptoms include fever, chills and flu-like illness, and without treatment, persons may develop kidney failure, seizures, mental confusion, coma and death. The approval of artesunate was largely based on two clinical trials comparing artesunate with quinine (a treatment no longer available) and finding the former drug to significantly lower the hospital mortality rate by 22.5% to 34.7%.
The most common adverse events were acute renal failure requiring dialysis, hemoglobinuria and jaundice.
Worldwide, artesunate is regularly used to treat malaria. The World Health Organization (WHO) recommends the use of artemisinin-based combination therapies for the treatment of uncomplicated malaria caused by the P. falciparum parasite. The choice of ACT should be based on the results of therapeutic efficacy studies against local strains of P. falciparum malaria. Most countries where malaria is prevalent have access to artemisinin-based combination therapies but its availability was limited to the expanded access program until now.
