An application for Tafenoquine has been sent to the FDA.
60 Degrees Pharmaceuticals (60P) revealed it submitted a New Drug Application (NDA) to the FDA for further clinical study of Tafenoquine. The drug has the potential to prevent the contraction of malaria.
Malaria is one of the most recognized of all infectious diseases and its transmission by Plasmodium parasites through mosquito hosts is well understood. Posing a significant risk to millions worldwide, malaria caused an estimated 429,000 fatalities (according to the CDC) in 2015. The risk for individuals traveling is attenuated, and 60P noted cases among travelers returning to the U.S. have been trending up, citing research showing 84% of the infected require hospitalization.
Dr. Stephen Toovey of Pegasus Research explained that to date, it has been tough finding effective drugs able to safeguard travelers and military personnel from malaria. "There are real problems with the few anti-malarial drugs we currently have, including both resistance and safety issues,” he said, noting "Tafenoquine should prove a useful alternative in combating malaria."
A first for the organization, Geoffrey Dow, 60 Degrees Pharmaceuticals’ CEO, explained that the work that has been done to date included significant legacy research at the Walter Reed Army Institute of Research, established Tafenoquine targets all types of malaria including the most common parasites (P. vivax and P. falciparum).
“We hope to market this product with a convenient weekly dosing regimen in the United States and eventually around the world," said Dow, concluding: "It is our belief our dossier will receive priority review, expediting the review of Tafenoquine, and 60P may qualify for a priority review voucher (PRV).” This, he said, will help the company acquire needed resources to provide the product to travelers as soon as possible.