FDA Committee Votes in Favor of New Malaria Prevention Treatment
The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee has voted in favor of tafenoquine (60 Degrees Pharmaceuticals) for the prevention of malaria in adults.
In clinical trials, tafenoquine, an 8-aminoquinoline, demonstrated efficacy against 2 primary types of malaria, Plasmodium vivax and P. falciparum malaria. The product is under review as a once-weekly treatment option that 60 Degrees hopes will provide convenience and improve compliance for individuals travelling to areas where malaria is endemic.
While the FDA is not bound to the Committee’s vote, the input is taken into consideration when reviewing the New Drug Application. If approved, the product will be marketed under the brand name Arakoda.