News Release

For Immediate Release -- August 10, 2018

Breakthrough in Malaria Prevention
USAMMDA Announces FDA Approval of New Antimalarial Drug

FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity (USAMMDA), Fort Detrick, Maryland, announced approval by the U.S. Food and Drug Administration (FDA) for the new antimalarial drug, tafenoquine (Arakoda). The new drug application for Arakoda, submitted by 60° Pharmaceuticals (60P) in partnership with the U.S. Army Medical Research and Materiel Command, received approval for the prevention of malaria today following priority review. This is the first new FDA-approved prophylactic drug for malaria in over 18 years.

Malaria, transmitted through the bite of an infected mosquito, is the top infectious disease threat to U.S. Military service members deployed overseas. Despite the use of prophylactic drugs and personal protective equipment, malaria remains a significant threat to the Warfighter. The malaria parasite has several life cycle stages during infection, including a blood and liver stage, which historically made treatment and prevention challenging. Tafenoquine is highly effective in the prevention of malaria, as it acts against multiple stages of the malaria parasite lifecycle. No other FDA-approved anti-malarial drug can provide this protection, which is a substantial improvement over the current therapies and has the potential to contribute to malaria eradication.

Arakoda fills a need for a safe and effective weekly malaria prevention drug. Current preferred options for malaria prophylaxis are limited to drugs that require daily dosing, which can have compliance issues. Additionally, Arakoda can replace the need for 14 days of dosing with the anti-malarial drug primaquine following travel to prevent relapsing malaria. Instead, Arakoda requires only a single dose following return from an area with malaria.

Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research. The approval was based on a concerted effort by the Army and 60P, involving over 25 clinical trials and over 3,000 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. To quote 60P's statement during a public meeting at the FDA, the drug is effective against "all parasites, everywhere, with a safe, simple dosing regimen."

Army Maj. Victor Zottig, product manager of tafenoquine for the Pharmaceutical Systems Project Management Office within USAMMDA, stated, "The recent approval of tafenoquine for a prophylactic indication by the FDA is a tremendous achievement for 60P and the U.S. Military for their long, dedicated effort in the global protection of service members and civilian personnel against malaria."

About USAMMDA
As the premier developer of world-class military medical capabilities, the USAMMDA is responsible for developing and delivering critical products designed to protect and preserve the lives of Warfighters across the globe. These products include drugs, vaccines, biologics, devices and medical support equipment intended to maximize survival of casualties on the battlefield.

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