The US Food & Drug Administration has granted Fast Track designation to 60 Degrees Pharmaceutical’s (60P) Tafenoquine for the prevention of malaria in adults.
IN December 2017, 60P submitted a New Drug Application to the FDA for the use of Tafenoquine to prevent malaria in adults travelling to areas where the disease is prevalent.
Malaria cases among travellers returning to the US have been trending upwards, with 84% of those infected requiring hospitalisation.
“Find acceptable drugs to safeguard travellers and deployed military personal against malaria is a real problem,” said 60P CEO Geoffrey Dow.
“We see Fast Track designation as a next step toward marketing this product with a convenient weekly dosing regimen in the US, and eventually around the world.”
In 2014, the company entered into a cooperative R&D agreement with the US Army Medical Material Development Activity to develop Tafenoquine as a weekly prophylactic drug for preventing malaria.