FDA OKs 60P’s 1st preventative antimalarial in almost two decades

60° Pharmaceuticals (60P) announced today the Food and Drug Administration (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.

Millions of healthy individuals travel to areas where malaria is endemic, including those traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces. ARAKODA™ has the potential to protect thousands of U.S. travelers from the devastating and life-threatening effects of malaria.

The marketing approval of ARAKODA™ is the culmination of years of scientific discovery and research by experts in the field of Malariology and Infectious Disease. 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.

“We have worked closely with the U.S. Army as their commercial partners to bring ARAKODA™ to the U.S. market,” said Geoffrey Dow, Ph.D, CEO of 60P. “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.” Dow continued, “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, the product manager of tafenoquine for the U.S. Army Medical Materiel Development Activity stated “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.”

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.

https://bit.ly/2MgfEHy