Tafenoquine

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.”

Single-Dose Tafenoquine to Prevent Relapse of Plasmodium vivax Malaria

Marcus V.G. Lacerda, M.D., Alejandro Llanos-Cuentas, M.D., Srivicha Krudsood, M.D., Chanthap Lon, M.D., David L. Saunders, M.D., Rezika Mohammed, M.D., Daniel Yilma, M.D., Dhelio Batista Pereira, M.D., Fe E.J. Espino, M.D., Reginaldo Z. Mia, M.D., Raul Chuquiyauri, M.D., Fernando Val, Ph.D., Martín Casapía, M.D., Wuelton M. Monteiro, Ph.D., Marcelo A.M. Brito, M.Sc., Mônica R.F. Costa, M.Sc., Nillawan Buathong, M.Sc., Harald Noedl, M.D., Ermias Diro, M.D., Sisay Getie, M.Sc., Kalehiwot M. Wubie, M.P.H., Alemseged Abdissa, Ph.D., Ahmed Zeynudin, M.Sc., Cherinet Abebe, M.D., Mauro S. Tada, M.D., Françoise Brand, M.Sc., Hans-Peter Beck, Ph.D., Brian Angus, M.D., Stephan Duparc, M.D., Jörg-Peter Kleim, Ph.D., Lynda M. Kellam, M.Sc., Victoria M. Rousell, B.Sc., Siôn W. Jones, Ph.D., Elizabeth Hardaker, M.D., Khadeeja Mohamed, M.Sc., Donna D. Clover, B.Sc., Kim Fletcher, B.A., John J. Breton, M.C.M., Cletus O. Ugwuegbulam, Ph.D., Justin A. Green, M.D., and Gavin C.K.W. Koh, Ph.D.

The New England Journal of Medicine

DOI: 10.1056/NEJMoa1710775

Abstract

BACKGROUND

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.

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