The development of tafenoquine for malaria prevention was completed by 60° Pharmaceuticals (60P) in collaboration with the U.S. Army in late 2017. Tafenoquine is currently undergoing priority review by the U.S. Food and Drug Administration for malaria prevention for up to six months in adults. Assuming regulatory approval is obtained, commercial launch is targeted for early 2019. Unlike the more well-known Plasmodium vivax indication where tafenoquine is given as a single dose to symptomatic individuals, the proposed label submitted by 60P to regulators involves continuous weekly dosing for up to six months in adults at risk of contracting malaria. Data from peer-reviewed clinical trials suggest that tafenoquine has activity against both P. falciparum and P. vivax. Structural, non-clinical, and clinical data from the literature suggest tafenoquine does not have a neurologic liability, but that G6PD testing is required to prevent inadvertent use in individuals with severe deficiency. Therefore, should tafenoquine receive marketing authorization, it may represent an improvement over the standard of care (mefloquine, chloroquine, daily drugs) in jurisdictions with robust G6PD screening capability. One can envisage, following the generation of additional clinical data, expansion of the proposed label to include children, dosing for up to 12 months, prevention of malaria amongst travelers between malaria-endemic countries, and outbreak prevention in countries declared malaria-free by the World Health Organization. 60P plans to conduct several post-marketing studies to allow these additional potential uses of tafenoquine for malaria prevention and eradication to be realized.
The opinions expressed herein are the author’s own and do not necessarily reflect those of the United States Army or Department of Defense.