Sanction of a single 300mg dose of GlaxoSmithKline’s tafenoquine in patients 16 years and above for the "radical cure" of malaria was advocated by an FDA advisory committee on finding significant evidence for its efficacy and safety.

While there was an undisputed vote on the evidence for efficacy (13-0), the evidence for adequate safety garnered enough support (12-1) barring one vote which suggested the need for ongoing post-marketing studies and surveillance.

Tafenoquine was ruled as adequately safe in the targeted population by the FDA's Antimicrobial Drugs Advisory Committee even after the discussed need for a G6PD test prior to the drug and two incidences of adverse psychiatric effects in the studies.

Peter Weina, MD, of Walter Reed National Medical Center in Bethesda, Maryland and committee member said, "We treat HIV and tuberculosis with multiple drugs all the time. Malaria, we have so much disrespect for it that we still treat it with a single drug that we hope is going to stick around for 50 or 60 years."

The three randomized trials that examined efficacy showed promising results though the committee noted that the trials only examined one dose of the drug, and there were unanswered questions about repetitive dosing and its use in cases of severe P. vivax malaria.

Larry Slutsker, MD, of global health organization PATH in Seattle called it a "potentially game-changing opportunity in [P. vivax] malaria." stating that most of the progress made against malaria in the past decade was against P. falciparum malaria, not P. Vivax.