The CDC has released new guidance on the treatment for severe malaria following the manufacturing discontinuation of the only FDA approved IV antimalarial.
A change in protocol for the treatment of severe malaria has been announced by the US Centers for Disease Control and Prevention (CDC). The agency announced today that as of April 1, 2019, artesunate will become the first-line treatment for severe malaria in the United States.
The new guidance was based upon the decision by the manufacturer of the antimalarial drug quindine, the only US Food and Drug Administration (FDA) approved intravenous (IV) antimalarial, to discontinue production of the drug.
IV artesunate is the first-line World Health Organization-recommended treatment for severe malaria. According to the CDC, clinical studies have shown that IV artesunate is safe and well-tolerated. Additionally, it is reported that the drug can be administered to infants and children, as well as pregnant women during the second and third trimesters and during lactation. The announcement further indicates that “in the first trimester of pregnancy, the benefits of IV artesunate treatment outweigh the risk of death and poor outcomes due to severe malaria.”
Malaria continues to remain a major source of illness and death across the globe, with an estimated 219 million cases, resulting in 435,000 deaths in 2017. In the US, an average of 1700 travelers return to the US with malaria with growing incidence rates. The CDC estimates that approximately 300 Americans return from abroad with severe malaria.
Despite the updated recommendations, artesunate is not FDA approved or commercially available in the United States; it is unknown when the drug will be approved, as a new drug application must be submitted. However, the CDC will make IV artesunate available through an expanded use investigational new drug protocol. The development of artesunate in the United States has been a collaboration between the Walter Reed Army Institute of Research and the US Army Medical Material Development Activity.
Clinicians who are treating a patient with severe malaria are required to call the CDC’s Malaria Hotline to obtain the drug. Following a consultation with a CDC expert who will determine if artesunate is needed, the drug will be provided for free to the CDC quarantine with the closest proximity to the health system where the clinician is operating.
The CDC will stock artesunate at 10 of the 20 US quarantine stations and anticipates that there will be a sufficient supply of the drug available for the treatment of all cases of severe malaria in the US.