FDA Approves Artesunate for Injection for Treatment of Severe Malaria

The FDA has approved Amivas US’ artesunate for injection (IV artesunate) 110 mg, powder and solvent for solution, for initial treatment of severe malaria in adult and pediatric patients. Artesunate for injection is on the World Health Organization Model List of Essential Medicines.¹

Prior to the FDA approval, IV artesunate was only available to patients through the FDA’s Expanded Access program, which allowed the CDC to provide IV artesunate to United States patients with severe malaria and to patients with uncomplicated malaria who are unable to take oral medications under an investigational new drug protocol.²

There has been no FDA approved drug for treatment of severe malaria in the US since the marketing of quinine was discontinued by the manufacturer in March 2019, according to the FDA.²

“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 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.”²

The safety and efficacy of IV artesunate for the treatment of severe malaria was primarily evaluated in a randomized controlled trial in Asia and a supportive published randomized controlled trial in Africa.²

Artesunate should not be used in patients with known serious allergy to artesunate such as anaphylaxis.²

REFERENCES

• Amivas (US), LLC Announces FDA Approval of Artesunate for Injection for Treatment of Severe Malaria [news release]. BioSpace. May 27, 2020. Accessed May 27, 2020. https://www.biospace.com/article/releases/amivas-us-llc-announces-fda-approval-of-artesunate-for-injection-for-treatment-of-severe-malaria/.
• FDA approves only drug in US to treat severe malaria. FDA. Published May 26, 2020. Accessed May 27, 2020. https://www.fda.gov/news-events/press-announcements/fda-approves-only-drug-us-treat-severe-malaria.