GlaxoSmithKline plc and Medicines for Malaria Venture submitted a new drug application to the U.S. Food and Drug Administration seeking approval for a malaria treatment, tafenoquine.
Single-dose tafenoquine is meant to prevent relapse of Plasmodium vivax malaria for patients over 16 years of age.
If approved, tafenoquine would be the first new medicine in more than 60 years that is intended to keep the strain of malaria from coming back. It was originally synthesized by scientists at the Walter Reed Army Institute of Research in 1978, and GSK entered a collaboration with Medicines for Malaria to develop it in 2008.
The submission includes phase 3 data studies conducted by GlaxoSmithKline in partnership with Medicines for Malaria. The FDA granted tafenoquine the breakthrough therapy designation in 2013.
GlaxoSmithKline plans to submit regulatory filings for the treatment in other countries in 2017 and 2018.
