GSK and Medicines for Malaria Venture (MMV) today announced the submission of a new drug application (NDA) by GSK to the United States Food and Drug Administration (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.

Mature Plasmodium vivax schizont/CDC
Mature Plasmodium vivax schizont/CDC

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.

Pauline Williams, Head of Global Health R&D, GSK said: “This regulatory filing marks a significant and historical milestone in our global health efforts. Treating Plasmodium vivax malaria is particularly challenging because the parasite can lie dormant in the liver resulting in relapses. 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. We look forward to the outcome of the filing.”

David Reddy, CEO of Medicines for Malaria Venture said, “MMV and GSK are committed to the development of single-dose tafenoquine for relapsing malaria. Following a long-standing partnership, we have now reached the exciting milestone of regulatory filing. This is significant because without treatment to stop the relapses, infected patients live with the constant threat of malarial symptoms returning without warning. Relapsing malaria thereby contributes significantly to the burden of disease in affected countries. The world has been waiting over 60 years for a new medicine for this indication. A single dose medicine would be unprecedented.”

Tafenoquine is not approved for use anywhere in the world. GSK plans to progress regulatory filings in other countries in 2017 and 2018.