Tafenoquine

Single-dose Kozenis (tafenoquine) approved for children with Plasmodium vivax malaria by Australian Therapeutic Goods Administration

Medicines for Malaria Venture (MMV) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of single-dose Kozenis (tafenoquine) in children aged 2 years and above in combination with chloroquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.

The approval includes a novel, 50 mg dispersible tablet that can be dispersed in water and which was developed by GSK in partnership with MMV to facilitate use in children, who are disproportionately affected by the disease.

The burden of relapsing P. vivax malaria on families

Nossa Senhora de Fatima is a remote village located in the middle of the Brazilian Amazon. In addition to being one of the most beautiful places in Brazil, the Amazonian region also accounts for 99.5% of all national malaria cases.

GSK, MMV filing for Kozenis (tafenoquine) in paediatric populations with Plasmodium vivax malaria accepted by Australian Therapeutic Goods Administration

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.

Brazil becomes first malaria-endemic country to approve single-dose tafenoquine (Kozenis) for radical cure of P. vivax malaria

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 versus Primaquine to Prevent Relapse of Plasmodium vivax Malaria

Alejandro Llanos-Cuentas, M.D., Marcus V.G. Lacerda, M.D., Tran T. Hien, M.D., Iván D. Vélez, Ph.D., Chayadol Namaik-larp, M.D., Cindy S. Chu, M.D., Maria F. Villegas, M.D., Fernando Val, Ph.D., Wuelton M. Monteiro, Ph.D., Marcelo A.M. Brito, M.D., Mônica R.F. Costa, M.D., Raul Chuquiyauri, M.D., Martín Casapía, M.D., Chau H. Nguyen, M.D., Sandra Aruachan, M.D., Ratchadaporn Papwijitsil, M.D., François H. Nosten, M.D., Germana Bancone, Ph.D., Brian Angus, M.D., Stephan Duparc, M.D., Graham Craig, B.Sc., Victoria M. Rousell, B.Sc., Siôn W. Jones, Ph.D., Elizabeth Hardaker, M.D., Donna D. Clover, B.Sc., Lindsay Kendall, M.Sc., Khadeeja Mohamed, M.Sc., Gavin C.K.W. Koh, Ph.D., Viviana M. Wilches, M.Biotech., John J. Breton, M.C.M., and Justin A. Green, M.D.

The New England Journal of Medicine

DOI: 10.1056/NEJMoa1802537

Abstract

BACKGROUND

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.”

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