US Service Member receives USAMMDA-developed, FDA-approved treatment for severe malaria

By Scotty HoganNovember 16, 2022

US Service Member receives USAMMDA-developed, FDA-approved treatment for severe malaria
USAMMDA’s Warfighter Protection and Acute Care (WPAC) Project Management Office (PMO) gathers for a group photo at the Fort Detrick, Maryland Headquarters. The WPAC PMO develops, delivers, fields, and sustains FDA-approved medical solutions for the prevention, diagnosis, and treatment of infectious diseases as well as the treatment of combat wound infections, acute pain and blood products. (Photo Credit: US Army courtesy photo) VIEW ORIGINAL

Fort Detrick, MD - The U.S. Army Medical Materiel Development Activity (USAMMDA) Warfighter Protection and Acute Care (WPAC) Project Management Office ) received notification Sept. 6, that the Camp Lemonnier, Djibouti Expeditionary Medical Facility had administered Malaria Treatment Drug Intravenous Artesunate, also known as MTD-IVAS, to a Service Member diagnosed with severe malaria. For patients diagnosed with severe malaria, treatment within the first eight hours is critical. Fortunately, the WPAC PMO’s deliberate planning and coordination to centrally procure and pre-position MTD-IVAS at OCONUS locations ensured the medication was immediately available, and the patient was later evacuated to the Landstuhl Regional Medical Center in Germany.

According to the Centers for Disease Control and Prevention, nearly half of the world’s population lives in areas where there is a risk of malaria transmission. In 2020 alone, the CDC estimated that 627,000 people around the globe died of malaria. Parasites, transmitted via mosquitos, cause malaria, and the disease’s symptoms can be mild, chronic, or severe. Severe malaria can result in a drastic decline in a patient’s condition over a 24-48 hour period and is fatal if not treated immediately.

“Because of shelf-life concerns and cost, the [Department of Defense] medical supply chain relies on just-in-time delivery for the vast majority of its pharmaceutical needs,” said Gerry LoSardo, logistics management specialist for WPAC PMO. “Intravenous Artesunate, however, posed some unique challenges.”

The drug launched commercially in 2021, and while distribution within the continental United States did not pose much of a challenge to USAMMDA’s industry partner Amivas LLC, the overseas supply chain infrastructure was not yet mature enough to ensure just-in-time delivery during the critical eight-hour window once a  patient had been  diagnosed with severe malaria. To address this issue, WPAC PMO carried out an initial procurement and pre-positioned MTD-IVAS at key locations within European and Indo-Pacific Commands, and U.S. Forces Korea.

“The intent of this plan was to ‘kick-start’ the supply chain and ensure the drug’s timely availability to malaria patients,” said LoSardo. “Execution of this plan included careful coordination across each of these commands to obtain concurrence with the pre-positioning strategy.”

The work done by the WPAC PMO put the only FDA-approved drug to treat severe malaria in the hands of the medical staff in Djibouti, enabling the timely administration of the drug and the Service Member’s evacuation to Landstuhl. This treatment marked the latest success of a years-long effort between USAMMDA and Amivas to develop this life-saving malaria drug, gain FDA approval, and distribute the drug globally.

“Having the treatment on-hand within that critical eight-hour window was very important,” said Michelle Mason, logistics management specialist at WPAC PMO. “It allowed the patient to be stabilized and evacuated, and at the end of the day, saving lives is all that matters.”

Development of similar treatments began at the Walter Reed Army Institute of Research (WRAIR) as far back as 2004 before being transitioned to USAMMDA’s WPAC PMO in 2009. Amivas joined the development in 2016, and MTD-IVAS was submitted for FDA approval in November 2019. The FDA approval process can be arduous, but with USAMMDA guidance MTD-IVAS was licensed by the FDA in May 2020.

"FDA approval of Artesunate for injection is another notable achievement for the U.S. Army in its long history of developing therapies for combating infectious diseases. With no alternate FDA approved therapies to treat life-threatening severe malaria, Artesunate for injection fills a critical gap for the military and U.S. population,” said Ryan Adams, Product Manager for WPAC PMO.