So far, most medicines for malaria target the pathogenic blood stages and treat the symptoms of the disease. This makes sense. It’s imperative to deal with the immediate suffering of a patient before looking at how to prevent future suffering. Yet, if malaria is to be eradicated, a broader range of medicines with different profiles is needed, not least medicines that can stop the relapse of malaria caused by the Plasmodium vivax parasite.
GSK and Medicines for Malaria Venture (MMV) today announced that the Australian Therapeutic Goods Administration (TGA) has approved single-dose Kozenis (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 the acute P. vivax infection.
A Marketing Authorization Application for tafenoquine for radical cure (prevention of relapse) of P. vivax malaria has been submitted by GSK to the Brazilian Health Regulatory Agency (ANVISA) under a priority review, making Brazil the first malaria-endemic country to evaluate the new single dose anti-relapse medicine. A priority review has been granted.
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.
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.
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 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.
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 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.