GSK files single-dose tafenoquine for P. vivax malaria with FDA

US pharma major GlaxoSmithKline (LSE: GSK) has submitted a New Drug Application to the US Food and Drug Administration, seeking approval of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax)malaria in patients 16 years of age and older.

Tafenoquine, an analog of primaquine, was first discovered by scientists at the Walter Reed Army Institute of Research in 1978 and is being developed in collaboration between GSK and Medicines for Malaria Venture (MMV).

If approved, tafenoquine would be the first new medicine for the prevention of relapse of P. vivax malaria in more than 60 years, potentially addressing the need for a single-dose and effective medicine for this debilitating disease, noted GSK.