USAMMDA PSPMO Receives Fast Track Designation for Tafenoquine
The U.S. Army Medical Materiel Development Activity, Fort Detrick, Maryland, announced that its Pharmaceutical Systems Project Management Office, with its commercial partner, 60 Degrees Pharmaceuticals LLC, received confirmation from the U.S. Food and Drug Administration that it has granted Fast Track designation for Tafenoquine for the prevention of malaria in adults. The FDA may grant Fast Track designation to facilitate the development and expedite the review of drugs indicated for a life-threatening disease or condition, addressing an unmet medical need.
Developed through a partnership between the U.S. Army and 60P, Tafenoquine is indicated to prevent malaria with a convenient weekly dosing regimen. Fast Track approval will allow for an expedited review of the new drug application recently submitted for Tafenoquine, requesting its use to prevent malaria in adults traveling to areas where malaria is known to occur.
"Achieving FDA licensure of Tafenoquine will provide a significant improvement over the current measures of malaria prevention for U.S. forces," said Dr. Lawrence Lightner, project manager for the PSPMO at USAMMDA. "Tafenoquine is only required to be administered weekly, while current preventive measures are required daily, and it protects against all forms of malaria." Malaria is transmitted through the bite of an infected mosquito, and remains the top infectious disease threat to U.S. military Service Members deployed overseas. The malaria parasite has several life cycle stages during infection, including a blood and liver stage, which has 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.
Tafenoquine was first discovered more than three decades ago at Walter Reed Army Institute of Research, and the drug eventually progressed into advanced development within the U.S. Army Medical Command. USAMMDA, a subordinate command of the U.S. Army Medical Research and Materiel Command, initiated a cooperative research and development agreement with 60P in 2014. Managed by USAMMDA's PSPMO, the effort has yielded successful results over the past three years in pursuit of an efficacious product.
"Our mission is to develop and deliver quality medical capabilities to protect, treat, and sustain the health of our Service Members," said Col. Ryan Bailey, commander of USAMMDA. "The Tafenoquine new drug application is a great example of how we intend to deliver solutions to protect our Service Members from the Malaria threat. This achievement is the result of significant research work and product development – a true team effort."
As the premier developer of world-class military medical capabilities, 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.