GlaxoSmithKilne and Medicines for Malaria Venture announced on Friday that tafenoquine, an investigational treatment for Plasmodium vivax malaria, received the Breakthrough Therapy designation from the U.S. Food and Drug Administration.
The Breakthrough Therapy designation is a new program for the FDA to accelerate the development and review of drugs for serious or life-threatening conditions.
Tafenoquine is an eight-aminoquinoline derivative that acts against P. vivax, which remains dormant in the liver and causes a relapse of infection weeks or months after the initial mosquito bite. The medication was given in single doses during clinical trials, and has not been approved or licensed for use by the FDA.
P. vivax malaria is a tropical disease that has a significant health and economic impact in South and Southeast Asia, Latin America and the horn of Africa. An estimated 70 million to 390 million clinical cases occur annually.
The FDA granted the Breakthrough Therapy designation based on results from Phase II clinical trials that took place internationally in multiple clinics with more than 300 patients.
Results of the clinical trial were presented at the American Society of Tropical Medicine and Hygiene meeting in November. Results also were published in The Lancet in December.
Phase III clinical trials of tafenoquine are planned for 2014.