
FDA grants marketing approval for US Army’s malaria treatment
pharmafile | May 28, 2020 | News story | Business Services | Malaria drug, US, US army, US., malaria
The FDA has granted marketing approval for the US Army Medical Research and Development Command’s (USAMRDC) Artesunate for injection, which is a treatment for severe malaria.
The drug was developed by the Walter Reed Army Institute of Research (WRAIR) and the US Army Medical Materiel Development Activity, a subordinate of the USAMRDC. The New Drug Application was submitted with Amivas USA, and was approved following review.
Army Major Victor Zottig, malaria product manager for USAMMDA’s Warfighter Protection and Acute Care Project Management Office, said: “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.”
The approval of Aresunate by injection will help fill the US’s need for an effective treatment for people suffering with severe malaria. Beforehand, the Army’s supply of the drug had only been available to Warfighters deployed overseas.
The initial development of the treatment in the US was led by the WRAIR who isolated the compound artemisinin from its natural source Artemisia annua, which is found on the banks of the Potomac River. Malaria is one of the top infectious disease threats to US military personnel stationed overseas.
Conor Kavanagh
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