Artesunate for Injection is an antimalarial drug indicated for the initial treatment of severe malaria in adult and paediatric patients. It is the only drug in the US to treat the condition.
The complete treatment course of patients with severe malaria comprises intravenous (IV) artesunate followed by an appropriate oral antimalarial regimen.
Artesunate for Injection has been included in the World Health Organization Model List of Essential Medicines, as well as in ‘artemisinin derivatives’ group of drugs.
Artesunate for Injection is available in a single-dose vial containing 110mg of artesunate in white, sterile, fine crystalline powder form for constitution with the supplied sterile diluent for intravenous injection.
Artesunate for Injection approval
An investigational new drug (IND) application for artesunate was submitted by the US Army Office of the Surgeon General (OTSG) in 2004.
Development of the drug has been controlled by US Army Medical Research and Development Command (USAMRDC). The Walter Reed Army Institute of Research (WRAIR) and the US Army Medical Materiel Development Activity (USAMMDA) collaborated under the USAMRDC for the constant supply of IV artesunate to the US Centers for Disease Control and Prevention (CDC), since 2007.
WRAIR / USAMMDA partnered with an Italian company Sigma-Tau Industrie Farmaceutiche Riunte to develop a new drug application (NDA) for the IND IV Artesunate to treat severe and complicated malaria, in July 2019.
USAMMDA collaborated with Amivas for the modernised manufacturing and registration of the product with the US Food and Drug Administration (FDA), under a research and development agreement.
The NDA received priority review status and Artesunate for Injection was approved in May 2020.
The drug was earlier available to patients only through the FDA’s Expanded Access programme of CDC. FDA approval of the Artesunate for Injection will improve the accessibility of the life-saving drug to patients.
Credit: Clinical Trials Arena