GSK has submitted a new drug application (NDA) to the US FDA for a single-dose tafenoquine for Plasmodium vivax malaria.
If approved, tafenoquine would be the first new medicine for the prevention of relapse of P vivax malaria in more than 60 years.
The submission follows the decision made by FDA in December 2013 to grant tafenoquine Breakthrough Therapy Designation.
The NDA submission includes Phase III data from the previously reported GATHER and DETECTIVE studies conducted by GSK in partnership with Medicines for Malaria Venture (MMV).
“Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver resulting in relapses,” said GSK’s Head of Global Health R&D Pauline Williams.
“Poor compliance to primaquine in real-world settings can lead to higher relapse rates than those seen in the controlled setting of clinical trials, so a single dose treatment is an attractive proposition.
“GSK and MMV have been working together since 2008 to develop single-dose tafenoquine as an alternative to primaquine. If approved, tafenoquine will potentially become an important tool to help eliminate P vivax malaria for good.”
Although Tafenoquine is not approved for use anywhere in the world, GSK plans to progress regulatory filings in other countries in 2018.