Amivas (US), LLC Announces FDA Approval of Artesunate for Injection for Treatment of Severe Malaria

May. 26, 2020

Artesunate for Injection 110 mg, powder and solvent for solution is approved by FDA for initial treatment of severe malaria in adult and pediatric patients.
Artesunate for Injection is in a group of drugs known as “artemisinin derivatives” and is on the World Health Organization Model List of Essential Medicines.
Since 2007, Investigational Intravenous (IV) Artesunate has been available in the US only through an expanded access investigational new drug (IND) program managed by the Centers for Disease Control and Prevention (CDC). FDA approval allows Amivas (US), LLC to manufacture, distribute and commercialize Artesunate for Injection.
Amivas was formed in 2016 expressly for the purpose of making this life-saving drug readily available in the US.
Approximately 2,000 US cases of malaria are diagnosed annually. Without appropriate treatment, about 15 percent become severe. Mortality from untreated severe malaria (particularly cerebral malaria) approaches 100 percent.