Advisory Group Recommends Safety, Efficacy of Malaria Drug

An FDA advisory committee agreed Thursday that 60 Degrees Pharmaceuticals proved the safety and efficacy of its NDA for tafenoquine indicated for the prevention of malaria in adults.

The Antimicrobial Drugs Advisory Committee voted 11-2 in favor of the drug’s efficacy, with supporters citing the strength of the clinical trial data.

Representatives of 60 Degrees Pharmaceuticals cited findings from clinical trials in which 3,184 subjects were exposed, with the recommended prophylactic regimen administered to 825 mostly healthy volunteers. Of 34 subjects who withdrew, only 16 pulled out because of adverse events potentially (but not “definitely”) linked to the drug.