60 Degrees Pharmaceuticals (60P) announced 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.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from American Pharmaceutical Review – all delivered right to your inbox! Sign up now!
"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.