FDA Advisory Committee Votes in Favor of Tafenoquine for Malaria Prevention
If approved, the product will be marketed under the brand name Arakoda.
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.
Recently, the FDA approved Krintafel (tafenoquine; GlaxoSmithKline) as a single-dose therapy for the radical cure of P. vivax malaria in patients ≥16 years old who are receiving appropriate antimalarial therapy for acute P. vivax infection.
For more information visit 60degreespharma.com.