FDA approves Arakoda for malaria prevention.- 60 Degrees Pharma.

60 Degrees Pharmaceuticals (60P) announced the FDA approval of Arakoda (tafenoquine) tablets for the prevention of malaria in patients aged 18 years and older. For the first time in more than eighteen years, the U.S. FDA approved a new drug for the prevention of malaria. Tafenoquine was originally discovered by scientists at the Walter Reed Army Institute of Research (WRAIR). The approval was based on a concerted effort by the U.S. Army and 60P, involving over 21 clinical trials and over 3,100 trial subjects, to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria.

Arakoda is supplied in 100 mg tablets for oral use only. After an initial loading dose prior to traveling, Arakoda is intended to be taken once a week which could offer convenience to the traveler. The U.S. FDA Anti-Microbial Drugs Advisory Committee recently recommended the approval of Arakoda for the prevention of malaria based on its safety and efficacy profile. 60P has committed to the U.S. FDA to perform post-marketing safety surveillance studies to continue to gather data on this important tool against malaria.