60 Degrees Pharmaceuticals announces Type C Meeting with FDA for tafenoquine

60 Degrees Pharmaceuticals announced that the U.S. Food and Drug Administration has granted a Type C meeting with the Company to consult on the path forward in developing the tafenoquine regimen of ARAKODA for a potential indication in treating hospitalized babesiosis patients. The meeting will take place on January 15, 2024. Tafenoquine is approved for malaria prophylaxis in the United States under the product name ARAKODA. The safety of the approved regimen of tafenoquine for malaria prophylaxis has been assessed in five separate randomized, double-blind, active comparator, or placebo-controlled trials for durations of up to six months. Tafenoquine has not been proven to be effective for treatment or prevention of babesiosis and is not approved by the FDA for such an indication. The efficacy and safety of 8-aminoquinolines, a class of drugs that includes tafenoquine and primaquine, for prevention and treatment of malaria is well established. The appearance of several case studies of tafenoquine use for babesiosis in the literature suggests that the drug is being used for this purpose in practice of medicine. The Company is planning an adequate and well controlled clinical study to evaluate this use systematically.