ASTMH Welcomes New Single-Dose P. Vivax Drug

Posted 12 June 2018

ASTMH Hopeful U.S. Approval of New Malaria Drug Will Reduce Suffering Worldwide

ASTMH welcomes the FDA’s approval of a new drug, Krintafel (tafenoquine), that can prevent relapse of Plasmodium vivax malaria with a single dose. The previously approved medication for P. vivax malaria requires a 14-day regimen that can be difficult for patients to comply with. Tafenoquine is approved as a single-dose treatment for radical cure of P. vivax malaria in patients 16 years and older and who do not have an enzyme problem, called G6PD deficiency, as it can cause severe anemia.
“This is victory for researchers who have been working for years to improve our current malaria medications and the millions of patients who have a better treatment option,” said President Regina Rabinovich, MD, MPH. “It’s important to note that this milestone was made possible through a 10-year partnership between a pharmaceutical company and a nonprofit drug developer, the Medicines for Malaria Venture, who together were able to blend their expertise for a drug targeted mostly to people in lower and middle-income countries.” Tafenoquine, the first new treatment approved specifically for P. vivax malaria in more than 60 years, was synthesized by scientists at the Walter Reed Army Institute for Research (WRAIR) in 1978.
Despite being much less known than its P. falciparum African counterpart, P. vivax is still a very significant cause of disease and death worldwide, with more than 2.5 billion people living at risk of being infected by this malaria parasite. According to the WHO, the P. vivax parasite is a major cause of malaria in the Americas, Southeast Asia and the Eastern Mediterranean. There were approximately 8.5 million cases of P. vivax in 2016, and malaria caused by this parasite can keep reoccurring months or even years after the initial infection if not treated properly. Additionally, P. vivax, formerly considered a "benign" parasite, is now recognized as being associated with severe disease, and even death.