FDA advisory committee recommends approval of Krintafel for malaria.- GlaxoSmithKline.

The Antimicrobial Drugs Advisory Committee (AMDAC) of the FDA 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 Krintafel (tafenoquine), from GlaxoSmithKline, for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.

Tafenoquine is not approved for use anywhere in the world. The new drug application was submitted by GSK to the FDA in November 2017. A regulatory submission was also made to the Australian Therapeutic Goods Administration in December 2017 with a decision anticipated in the next few months. Approvals of tafenoquine by the FDA and TGA would help support registrations in countries where P. vivax malaria is endemic, and would be first steps on the path to global adoption of the new medicine.