Tafenoquine’s approval was the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease, involving over 25 clinical trials and over 3000 participants.
Tafenoquine (Arakoda), the first prescription drug approved for the prevention of malaria in adults, is now available in the United States, according to a press release. Tafenoquine has the potential to protect thousands of US travelers and military personnel from the effects of malaria.
"Malaria is one of the most malicious diseases, on the rise in both US and other parts of the world," Geoffrey Dow, chief executive officer of 60P Pharmaceuticals, said in a statement. "It poses a significant risk to millions of healthy individuals traveling to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces."
Tafenoquine was the first antimalarial product approved for the prevention of malaria in over 18 years. The approval was the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease, involving over 25 clinical trials and over 3000 participants.
One such multicenter, double-blind, randomized trial was published in the New England Journal of Medicine and enrolled 522 patients with microscopically confirmed Plasmodium vivax, a protozoal parasite and most widely distributed cause of recurring malaria.2
More than 62% was free from recurrence at 6 months in the tafenoquine group compared with the approximate 28% in the placebo group. According to the study, single-dose tafenoquine resulted in a significantly lower risk of P. vivax recurrence than placebo in patients with phenotypically normal glucose-6-phosphate dehydrogenase activity.2
Malaria is a life-threatening disease transmitted through the bite of an infected mosquito, causing an estimated 429,000 fatalities and 212 million clinical cases in 2015, according to the CDC. Malaria cases among travelers returning to the United States have been trending upwards.
The first significant shipment of tafenoquine occurred in September 2019 to the United States Army. The product is now commercially available via select retail pharmacy outlets and pharmaceutical wholesalers.