For the first time in near two decades, the FDA has approved a new drug for the prevention of malaria. ARAKODA™, the brand name for Tafenoquine, will be produced in tablet form and used by those over the age of 18. Its marketing approval under the name of ARAKODA™ presents a milestone after years of research and discovery in the antimalarial field.
If you would like to learn more about the drug, you can listen to our exclusive set of interviews regarding Tafenoquine.
The approval was based on medicinal trials made by 60P and the US Army including over 21 clinical trials and over 3,100 trial subjects, in an effort to develop tafenoquine as a weekly prophylactic drug, effective for the prevention of malaria.
In a press statement made by 60P, CEO Geoffrey Dow explained that:
“ARAKODA™ provides effective protection against both of the major types of malaria (P. vivax and P. falciparum), killing the parasites in both the blood and liver”
“this provides the travel medicine community the option to prescribe an anti-malarial which provides protection in a large spectrum of malaria hot zones while utilizing what is considered by many physicians to be a more compliant dosing regimen. ARAKODA™ is a significant addition to the armamentarium for the prevention of malaria.”
MAJ Victor Zottig, product manager, tafenoquine for the U.S. Army Medical Materiel Development Activity added that:
“The FDA approval is a tremendous achievement for 60P and the U.S. military for their long, dedicated effort in the global protection of Service Members and civilian personnel against malaria.”
Despite recent criticisms made by firms and high profile figures over Tafenoquine’s dangerous potential side effects, the U.S. FDA Antimicrobial Drugs Advisory Committee recently recommended the approval of ARAKODA™ for “the prevention of malaria based on its safety and efficacy profile”