Amivas’s Artesunate Receives the US FDA’s Approval for Treatment of Severe Malaria

Shots:

• Amivas’ Artesunate for Injection (110 mg) is a powder and solvent for solution US FDA approved and is targeted for initial treatment of severe malaria in adult and pediatric patients
• Artesunate’s (IV) safety and efficacy was examined vs standard of care drug in three trials including the South East Asian Quinine Artesunate Malaria Trial (SEAQUAMAT) and the African Quinine Artesunate Malaria Trial (AQUAMAT) enrolling 6,886 patients and reported reduced mortality (34.7% vs 22.5%)
• The CDC will continue the process of manufacturing investigational IV artesunate available under the CDC-sponsored expanded access IND 76,725, in effect per FDA’s authorization since 2007 until nationwide availability of Amivas-produced Artesunate for Injection is in place in the next few months

Click here to read full press release/ article | Ref: Amivas | Image: Amivas