60 Degrees Pharmaceuticals (60P) received Priority Review Designation from the FDA for Tafenoquine (TQ), for the prevention of malaria in adults.  

This comes after the January 2018 reception of  Fast Track Designation for the use of Tafenoquine to prevent malaria in adults traveling to areas where the disease is prevalent.   

Malaria cases among travelers returning to the U.S. are trending upwards, with 84% of those infected requiring hospitalization.

“We see Priority Review, following our Fast Track Designation, as a validation of the importance of this therapy. TQ will provide a significant improvement over currently available therapies. TQ has the advantage of a convenient weekly dosing regimen which will help travelers comply and protect themselves from malaria parasite(s) while in endemic regions of the world” said Geoffrey Dow, Ph.D., chief executive officer of 60 Degrees Pharmaceuticals.

In 2014, 60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity to develop Tafenoquine, which was discovered at the Walter Reed Army Institute of Research. An analysis of five clinical trials to assess the safety and tolerability of Tafenoquine has recently been published in Travel Medicine and Infectious Disease, a peer reviewed journal. The authors concluded that Tafenoquine appeared to be safe and well tolerated when the anticipated clinical regimen (ACR) was administered.