US FDA committee recommends approval malaria drug, Tafenoquine

60 Degrees Pharmaceuticals (60P) has announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (FDA) voted to support Tafenoquine, an investigational drug for the prevention of malaria in adults, voting (11 for; 2 against) on its efficacy and (9 for; 4 against) for its safety.

Tafenoquine will be marketed under the brand name Arakoda.

“If approved, we feel Tafenoquine will provide a significant advancement in protecting individuals traveling to parts of the world where malaria is endemic,” said Dr. Geoffrey Dow, CEO, 60P. “Arakoda could be an ideal option for people traveling for leisure, employees of non-governmental organizations, industrial and business workers, and military forces.” Tafenoquine is a convenient once-a-week dosing option, which could help ensure compliance while on travel. Clinical trials indicate the product is effective against the two primary types of malaria (P. Vivax and P. Falciparum).

AMDAC provides the FDA with independent advice from outside experts on issues related to infectious diseases. The advisory committee provides recommendations for the FDA to consider about the safety and efficacy of a drug. The FDA, however, makes the final decisions.

In December, 60P submitted a new drug application (NDA) to the FDA for the use of Tafenoquine to prevent malaria in adults. A regulatory submission was also made to the Australian Therapeutic Goods Administration (TGA) in September 2017.

• Tafenoquine is an 8-aminoquinoline chemically derived from Primaquine, with activity against all types of malaria.
• It was first synthesized by scientists at the Walter Reed Army Institute of Research in 1978.

60P entered into a cooperative research and development agreement with the US Army Medical Materiel Development Activity (US AMMDA) 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 NDA submission is a culmination of over 30 years of research and development with the US Army Medical Research and Materiel Command, from the discovery of Tafenoquine at the Walter Reed Army Institute of Research through the current collaboration between 60P and US AMMDA.

The regulatory submission included efficacy and safety data on tafenoquine from animal studies and 21 clinical trials involving more than 3,100 participants who have taken tafenoquine.

60P, founded in 2010, focuses on discovering, developing and distributing new medicines for treatment and prevention of tropical diseases, including malaria and dengue.