The US FDA has granted breakthrough therapy designation to GlaxoSmithKline's (GSK) and Medicines for Malaria Venture's (MMV) experimental drug tafenoquine as to treat and prevent relapse of Plasmodium vivax malaria, a neglected tropical disease, which is a major cause of uncomplicated malaria.
The breakthrough status is intended to expedite the regulatory review process, giving firms the opportunity to meet with the FDA's review team throughout the development of the drug and receive timely advice and interactive communication to ensure the medicine's investigational program is as efficient as practicable (scripintelligence
