The U.S. Army Medical Research and Development Command announced today that the U.S. Food and Drug Administration granted marketing approval for Artesunate for Injection, an initial treatment for severe malaria.
The drug was developed under current Good Manufacturing Practices by the Walter Reed Army Institute of Research and the U.S. Army Medical Materiel Development Activity, subordinate commands of USAMRDC. The New Drug Application for Artesunate for Injection was submitted by Amivas USA, LLC, specialists in treatments for rare and neglected tropical diseases, in collaboration with USAMMDA through a cooperative research and development agreement, and received approval following priority review.
The FDA approval of Artesunate for Injection is another notable achievement for the U.S. Army in its long history of developing therapies for combating malaria. With a lack of alternate FDA-approved therapies to treat life-threatening severe malaria, Artesunate for Injection fills a critical gap for the military and U.S. population."
Army Maj. Victor Zottig, malaria product manager for USAMMDA's Warfighter Protection and Acute Care Project Management Office
Malaria, transmitted through the bite of an infected mosquito, is one of the top infectious disease threats to U.S. military personnel deployed overseas. Despite the use of prophylactic drugs and personal protective equipment, malaria remains a significant threat to the Warfighter. Left untreated, severe malaria can lead to prolonged convalescence or death.
Artesunate for Injection's approval will fill a nationwide need for a safe and effective treatment drug for patients suffering from severe malaria. To this point, the Army's manufactured supply of artesunate under an Investigational New Drug application has been the only available option for Warfighters deployed overseas. Artesunate has been available through a Force Health Protection protocol, under the Army Office of the Surgeon General-sponsored treatment Investigational New Drug, and domestically through the Centers for Disease Control and Prevention's treatment protocol. The only other FDA-approved treatment option, intravenous quinidine, was discontinued in 2019. The marketing approval of Artesunate for Injection will allow military and civilian hospitals the ability to obtain the drug commercially to treat this deadly disease.
"It's always a great day when the discoveries of our world-class team of scientists become a tangible product that will save the lives of our Warfighters," said Army Lt. Col. Mara Kreishman-Deitrick, director of the Experimental Therapeutics Branch at WRAIR.
Artesunate's initial development in the U.S. was led by a team of researchers from WRAIR who reported the first Western isolation of the compound artemisinin from its natural plant source, Artemisia annua, found on the banks of the Potomac River. After an extensive medicinal chemistry campaign to optimize the artemisinin class, artesunate was identified as a promising clinical candidate and ultimately selected for clinical development.
The IND application for artesunate was filed by the Army OTSG under a joint WRAIR/USAMMDA partnership in 2004. WRAIR then began research and development efforts of artesunate to improve upon the drug's pharmacokinetics. The first regulated Phase 1 trial was completed in 2006, followed by a Phase 2 trial that was conducted in Kenya. Artesunate was transitioned to USAMMDA in 2009 for medical product development and management. USAMMDA assisted in the NDA preparation, filing and review process, providing clinical and other regulatory data required to support the NDA submission and numerous FDA information requests.
"This difficult undertaking was accomplished through a competitively bid, public/private partnership and is testament to the professionalism and dedication of the team involved," said Zottig.