GSK and Medicines for Malaria Venture (MMV) have announced that the Antimicrobial Drugs Advisory Committee (AMDAC) of the United States Food and Drug Administration (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 tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients 16 years of age and older.
“If approved, tafenoquine would be the first new medicine for this indication in more than 60 years”
The AMDAC is convened to provide the FDA with independent expert advice on a broad range of issues related to infectious diseases and disorders. The committee provides non-binding recommendations for consideration by the FDA, with the final decision on regulatory approval made by the FDA.
Tafenoquine is not approved for use anywhere in the world. The new drug application (NDA) was submitted by GSK to the FDA in November 2017. A regulatory submission was also made to the Australian Therapeutic Goods Administration (TGA) 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.
Pauline Williams, Head of Global Health R&D, GSK said: “After extensive efforts to develop a new treatment for patients with P. vivax malaria, working in collaboration with Medicines for Malaria Venture, we welcome this endorsement. If approved, tafenoquine would be the first new medicine for this indication in more than 60 years. Together with our partners, we look forward to the final decision by the FDA.”
David Reddy, CEO of Medicines for Malaria Venture said: “MMV welcomes the outcome of today’s Advisory Committee meeting. Our 12-year collaboration with GSK on this project has resulted in the development of a medicine with the potential to improve the management of P. vivax malaria, offering a single-dose radical cure. The positive vote is an important step towards tafenoquine becoming a significant addition to the global anti-malaria arsenal.”