Brazil approves single-dose tafenoquine for radical cure of P. vivax malaria

UK pharma major GlaxoSmithKline’s (LSE: GSK) Brazil subsidiary and Medicines for Malaria Venture (MMV) announced late Wednesday 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.

Although tafenoquine was approved by the US Food and Drug Administration under the Krintafel trade name in July 2018, making it the first new treatment for Plasmodium vivax malaria in over 60 years, and subsequently in Australia, where it is marketed as Kozenis, Brazil is the first malaria-endemic country to approve the product.

The Ministry of Health, in partnership with MMV, will conduct a study to understand the feasibility of implementing quantitative point-of-care G6PD testing with tafenoquine in real-world settings before treatment is made available in Brazil. This study, known as TRuST is being conducted in the municipalities of Manaus and Porto Velho. The study outcomes, expected in the first quarter of 2021, will assist the Ministry of Health to determine how to best deploy tafenoquine in P. vivax endemic areas.

Single dose facilitates compliance