Priority Review Designation Received for Tafenoquine
Point of Contact:
Public Affairs Specialist
U.S. Army Medical Materiel Development Activity
FOR IMMEDIATE RELEASE
FORT DETRICK, Md. – The U.S. Army Medical Materiel Development Activity (USAMMDA) announced the U.S. Food and Drug Administration granted priority review designation for Tafenoquine Feb. 7. Tafenoquine is intended to prevent Malaria in adults.
"Obtaining FDA priority review designation is another major step in accelerating this critically needed product through the regulatory review process towards licensure and fielding," said Dr. Lawrence Lightner, USAMMDA project manager for the Pharmaceutical Systems Project Management Office.
The U.S. FDA may grant priority review designation for drugs intended for the prevention of serious conditions, such as malaria, that provide safety or efficacy improvements over currently available drugs.
Malaria is a serious, life-threatening disease, transmitted through the bites of infected mosquitoes. Malaria is a top infectious disease threat to U.S. Service Members deployed overseas, and also poses a significant risk to travelers in many parts of the world.
Tafenoquine was discovered by the Walter Reed Army Institute of Research more than thirty years ago. In 2014, Tafenoquine transitioned to USAMMDA where a cooperative research and development agreement with 60° Pharmaceuticals was initiated.
Fast Track designation for Tafenoquine was granted by the U.S. FDA in January 2018.
"This priority review designation is the culmination of immense work by the entire product management team and our commercial partner," said MAJ Victor Zottig, product manager for Tafenoquine in the PSPMO at USAMMDA. "We are happy that the FDA agrees with the importance of this drug."
USAMMDA is the DOD's advanced development activity for products designed to protect and preserve the lives of Warfighters. USAMMDA develops new drugs, vaccines and medical support equipment that enhance readiness, ensures the provision of the highest quality medical care to the DOD and maximizes survival of medical casualties on the battlefield.