Amivas’ Artesunate Approved for Severe Malaria
Amivas has received the FDA’s approval for its artesunate injection for treatment of severe malaria in adult and pediatric patients.
The approval was based on the results of two clinical trials, in which fewer patients treated with artesunate died compared to those treated with quinine.
Artesunate is the first FDA-approved drug for severe malaria since quinine was discontinued in March 2019. The drug was previously only available to patients through the FDA’s Expanded Access program.