60 Degrees Pharmaceuticals (60P) has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent.
Malaria, a life-threatening disease caused by Plasmodium parasites that are transmitted to people through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015. It poses a significant risk to millions of healthy individuals traveling in many parts of the world, including employees of non-governmental organizations (NGOs), casual vacationers, industrial and business workers, and military forces. Malaria cases among returning travelers in the U.S. have been trending upwards, with 84% of those infected requiring hospitalization.
"There are real problems with the few anti-malarial drugs we currently have, including both resistance and safety issues. In particular, there can be a problem finding acceptable drugs to safeguard travelers and deployed military personnel," said Dr. Stephen Toovey, Pegasus Research. "Tafenoquine should prove a useful alternative in combating malaria."
60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop Tafenoquine as a weekly prophylactic drug for the prevention of malaria. As malaria is the top infectious disease threat to U.S. Military service members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships.
The NDA submission is a culmination of over 30 years of research and development with the U.S. Army Medical Research and Materiel Command, from the discovery of Tafenoquine at Walter Reed Army Institute of Research (WRAIR) through the current collaboration between 60P and USAMMDA.
Researched for more than 30 years for both the prevention and treatment of malaria, Tafenoquine works against the major malaria parasites and all stages of the parasite's lifecycle. Tafenoquine has been studied in more than 30 clinical trials involving more than 4,000 study participants.