The public-private initiatives that contributed to COVID-19 vaccine and drug development have showcased a model for accelerating biomedical innovation. This is another powerful example of how public-private partnerships have established themselves as powerhouses for fighting global health threats.
GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.
The application includes data for a new, 50 mg tablet that can be dispersed in water and which was developed to facilitate use in children, who are disproportionately affected by the disease.
GSK Brazil and Medicines for Malaria Venture (MMV) today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted Marketing Authorization Approval, under Priority Review, for single-dose tafenoquine (brand name Kozenis) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving chloroquine for acute P. vivax (blood-stage) infection.
Tafenoquine, a single-dose therapy for Plasmodium vivax malaria, has been associated with relapse prevention through the clearance of P. vivax parasitemia and hypnozoites, termed “radical cure.”
Treatment of Plasmodium vivax malaria requires the clearing of asexual parasites, but relapse can be prevented only if dormant hypnozoites are cleared from the liver (a treatment termed “radical cure”). Tafenoquine is a single-dose 8-aminoquinoline that has recently been registered for the radical cure of P. vivax.
Half the world’s population lives at risk of the Plasmodium vivax malaria parasite. Once it has infected the human body, it can lie dormant in the liver, hidden from standard antimalarial medicines, and reawaken at regular intervals causing a malaria bouts in the absence of a mosquito bite.
GSK and Medicines for Malaria Venture (MMV) today announced the publication of positive results from two phase III studies of single-dose tafenoquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in The New England Journal of Medicine.