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



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



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.

Overcoming challenges to tackle malaria relapse

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.

Working to Stop Malaria Relapse for Good

Brice Campo, Director Drug Discovery, MMV

ASTMH Annual Meeting 2018 blog

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.


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