Malaria Rx Gets FDA Nod Leave a comment


(RxWiki News) The US Food and Drug Administration (FDA) has approved a drug to treat severe malaria.

This approval is for (IV) artesunate. The FDA approved it to treat adults and children with severe malaria. Since the marketing of quinidine was stopped last spring, there has not been an FDA-approved drug approved to treat severe malaria in the US.

Before this approval, this medication was only available to patients through the FDA’s Expanded Access program. This program allowed the Centers for Disease Control and Prevention (CDC) to provide this medication to patients under an investigational new drug protocol.

“This approval will now give patients more access to a lifesaving drug,” said Dr. John Farley, acting director of the FDA’s Office of Infectious Diseases, in a press release. “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.”

Malaria may be considered “severe” when any of the following symptoms, among others, occurs:

  • Impaired consciousness
  • Seizures
  • Pulmonary edema or acute respiratory distress syndrome (ARDS)
  • Acidosis
  • Acute kidney injury
  • Abnormal bleeding

Artesunate is to be administered in the vein by a health care professional. After treatment with artesunate, patients are to be given a complete treatment plan of medications that are to be taken by mouth.

An estimated 2,000 cases of malaria are diagnosed in the United States each year, according to the CDC. And about 300 of these cases are considered severe.

Malaria is transmitted by mosquito bites and results in fever, chills and flu-like illness. Without the right treatment, people may develop serious complications, such as kidney failure and mental confusion.

Cases in the US are typically related to travel. That means people acquire malaria while traveling to other countries that have high malaria rates.

The safety and efficacy of artesunate was studied in two randomized controlled trials: one trial in Asia and a supportive trial in Africa.

Side effects of artesunate may include jaundice and acute kidney failure that requires dialysis. This medication is not intended for those who have a serious allergy to artesunate, the FDA noted.

The approval of this medication was granted to Amivas.


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