A pharmaceuticals company has received fast-track designation from the U.S. Food and Drug Administration for the production of a drug that could possibly prevent malaria in adults.
In December, 60 Degrees Pharmaceuticals submitted a new drug application (NDA) for the use of Tafenoquine to prevent malaria in adults traveling to areas where the disease remains prevalent.
Malaria, a life-threatening disease transmitted through the bite of an infected mosquito, caused an estimated 429,000 fatalities and 212 million clinical cases in 2015.
The pharmaceutical company contends the disease poses a significant risk to millions of healthy individuals traveling in many parts of the world, including employees of nongovernmental organizations, casual vacationers, industrial and business workers, and military forces.
Malaria cases among travelers returning to the U.S. have been trending upwards, with 84 percent of those infected requiring hospitalization, the company said.
The company entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity in 2014 to develop Tafenoquine as a weekly prophylactic drug for the prevention of malaria.
A drug is designated as a fast-track product “for the treatment of a serious or life-threatening disease or condition, and it demonstrates the potential to address unmet medical needs for such a disease or condition,” according to the FDA.
Since malaria is the top infectious disease threat to service members overseas, the U.S. military maintains a 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.
A recent analysis of five clinical trials to assess the safety and tolerability of Tafenoquine has 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.
“Finding acceptable drugs to safeguard travelers and deployed military personnel against malaria is a real problem,” said Geoffrey Dow, CEO of 60 Degrees. “We see Fast Track Designation as a next step toward marketing this product with a convenient weekly dosing regimen in the United States, and eventually around the world. It is our continued belief our dossier will receive priority review, thereby expediting the review of Tafenoquine.”