FDA grants fast-track designation to malaria drug Tafenoquine

The US Food and Drug Administration (FDA) has granted fast-track designation to 60 Degrees Pharmaceuticals’ (60P) Tafenoquine for the prevention of malaria in adults.

60P submitted the new drug application (NDA) for Tafenoquine in December last year, seeking approval for the use of the drug in adults who travel to areas prevalent with malaria.

The incidence of malaria infection, which is considered as a life-threatening disease, is reported to have been increasing in travellers returning to the US.

In 2014, the firm signed a cooperative research and development agreement with the US Army Medical Materiel Development Activity (USAMMDA) for the development of the drug as a weekly prophylactic medicine.

60 Degrees Pharmaceuticals CEO Geoffrey Dow said: "We see fast-track designation as a next step towards marketing this product with a convenient weekly dosing regimen in the US, and eventually around the world.

"It is our continued belief our dossier will receive priority review, thereby expediting the review of Tafenoquine. This better positions 60P for a priority review voucher (PRV) thus assisting 60P to acquire needed resources to launch Tafenoquine."

During an analysis of five clinical trials, carried out to investigate the safety and tolerability of Tafenoquine, the drug was found to be safe and well-tolerated upon administration of the anticipated clinical regimen (ACR).

All five trials are reported to have demonstrated adverse events (AEs), the majority of which were mild or not related to Tafenoquine.