Tafenoquine

Plasmodium vivax

Around 8.5 million clinical infections every year are caused by P. vivax.1 Many of these are relapses from existing infections that occur in the absence of new infective mosquito bites. This occurs because P. vivax parasites can lie dormant in the liver as hypnozoites, reactivating weeks, months or even years after initial infection.

US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria

GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

GSK submits US regulatory application for single-dose tafenoquine for Plasmodium vivax malaria

GSK and 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.

MMV Project of the Year award - 2016

Three discovery teams led by Prof. Dennis Kyle, Prof. Elizabeth Winzeler and Dr Jetsumon Sattabongkot Prachumsri jointly received the MMV Project of the Year 2016 award for their impressive progress in developing new assay platforms to test compounds for activity against the liver stages of malaria. These new assays are now making it possible to screen and identify novel compounds that could stop the relapse and protect against malaria.

Tafenoquine - a potential medicine to prevent P. vivax relapse

Tafenoquine is an investigational medicine that has completed phase III studies. If approved, it would be the first new medicine for relapsing malaria in over 60 years. Tafenoquine will potentially offer a single-dose cure for the liver-stage of P. vivax infections and will be administered alongside a standard 3-day chloroquine or potentially an ACT treatment regimen. 

Aiming to stop relapsing malaria with a single-dose treatment

Tafenoquine is an investigational medicine that has completed phase III studies. If approved, it would be the first new medicine for relapsing malaria in over 60 years. Tafenoquine will potentially offer a single-dose cure for the liver-stage of P. vivax infections and will be administered alongside a standard 3-day chloroquine or potentially an ACT treatment regimen. 

First single-dose medicine to prevent the relapse of P. vivax approved by US FDA

On 20 July 2018, GSK and MMV announced that the United States Food and Drug Administration (FDA) approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.

Discovering new medicines for relapsing malaria

Issue

Currently, primaquine is the only treatment available to prevent the relapse of Plasmodium vivax malaria. However, as per the primaquine label and WHO recommendations, it is administered once daily for 14 days – a regimen that is hard for patients to comply with, meaning that many are not cured. A single-dose treatment with the potential to improve patient compliance would positively impact P. vivax control and elimination efforts.

Tafenoquine - aiming to stop relapsing malaria

Tafenoquine is an investigational medicine in phase III development. If approved, it would be the first new medicine to cure relapsing malaria in over 60 years. Tafenoquine is being developed as a single dose to prevent malaria relapse, to be administered alongside a standard 3-day ACT to cure the immediate infection. 

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