FDA advisory panel backs approval of first new malaria drug in 60 years

The US Food and Drug Administration’s Antimicrobial Drugs Advisory Committee (AMDAC) at its meeting on Thursday voted that there is substantial evidence of the effectiveness (13 for; 0 against) and adequate evidence of the safety (12 for; 1 against) of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax)malaria in patients aged 16 years 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 under a collaboration between UK pharma major GlaxoSmithKline (LSE: GSK), whose shares edged up 1.5%, and Medicines for Malaria Venture (MMV).

Pauline Williams, head of global health R&D, GSK, said: “After extensive efforts to develop a new treatment for patients with P. vivax malaria, working in collaboration with Medicines for Malaria Venture, we welcome this endorsement.If approved, tafenoquine would be the first new medicine for this indication in more than 60 years. Together with our partners, we look forward to the final decision by the FDA.”