US Food and Drug Administration Approves ARAKODA™ (tafenoquine) tablets for oral use; First preventative antimalarial approved in almost two decades
Published: Aug 09, 2018
WASHINGTON, /PRNewswire/ --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.
Important Safety Information
Warnings and Precautions
Use in Specific Populations
To report SUSPECTED ADVERSE REACTIONS, contact 60 Degrees Pharmaceuticals at 1-888-834-0225 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
60P entered into a cooperative research and development agreement with the U.S. Army Medical Materiel Development Activity (USAMMDA) in 2014 to develop tafenoquine as a weekly prophylactic drug for the prevention of malaria. Since malaria is the top infectious disease threat to U.S. military Service Members overseas, the military maintains a robust anti-malarial drug development effort through internal research and commercial partnerships. The FDA approval is a culmination of over 30 years of research and development with the U.S. Army Medical Research and Materiel Command, from the discovery of tafenoquine at WRAIR through the current collaboration between 60P and USAMMDA.
Further information is available on the company's website, www.60degreespharma.com .
The statements contained herein may include prospects, statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance or events may differ materially from those expressed or implied in such forward-looking statements.
The statements expressed herein are those of 60P and do not necessarily represent those of the U.S. Department of Defense or Department of the Army.
1 Cullen KA, Mace KE, Arguin PM. Malaria Surveillance-United States, 2013 MMWR Surveillance Summary 2016:65 (No.SS-2);1-22 DOI: http://dx.doi.org/10.15585/mmwr.SS6502a1
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SOURCE 60 Degrees Pharmaceuticals