Posted by Michael Wonder on 29 Nov 2017
GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria
29 November 2017 - Regulatory milestone affirms GSK's strong commitment and scientific capabilities to fighting infectious diseases.
GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application by GSK to the United States FDA, seeking approval 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 the prevention of relapse of P vivax malaria in more than 60 years, potentially addressing the need for a single-dose and effective medicine for this debilitating disease.
The submission follows the decision made by FDA in December 2013 to grant tafenoquine breakthrough therapy designation, an initiative aimed at expediting the development and review times of drugs for serious or life-threatening conditions. The NDA submission includes Phase III data from the previously reported GATHER and DETECTIVE studies conducted by GSK in partnership with MMV.
