EMA Endorses Injectable Malaria Drug Artesunate

Lucy Hicks

September 17, 2021

The European Medicines Agency's human medicines committee has recommended approval for an intravenous treatment for severe malaria.

The Committee for Medical Products for Human Use (CHMP) adopted a positive opinion for artesunate (Artesunate Amivas) for the initial treatment of severe malaria in adults and children during a meeting this week. The drug is classified as an orphan drug because of malaria's low prevalence in the European Union.

Artesunate is administered intravenously, with the first three doses given during a 24-hour period, at 0, 12, and 24 hours. The drug is then given once daily until the patient can begin oral antimalaria therapy. The US Food and Drug Administration approved intravenous artesunate in May of last year.

According to the European Centre for Disease Prevention and Control, there were 8638 confirmed cases of malaria in the European Union/European Economic Area in 2019. Common symptoms are fever, chills, and nausea, but if left untreated malaria can lead to serious complications like kidney failure, severe anemia, and seizures.

With a positive opinion of artesunate from CHMP, the drug now awaits official approval by the European Commission, which normally occurs within 60 days.

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