Brazil becomes the first malaria-endemic country to register single-dose tafenoquine for children with relapsing malaria
Medicines for Malaria Venture (MMV) is pleased to announce that Anvisa, the National Regulatory Agency for Brazil, has approved the use of single-dose tafenoquine (Kozenis1) in children aged 2 years and above in combination with chloroquine for the radical cure of Plasmodium vivax (P. vivax) malaria. Brazil is the first malaria endemic country to approve the use of tafenoquine for children. This represents a significant step forward in the fight against malaria: a single-dose treatment option could lead to more children being effectively protected against debilitating P. vivax malaria relapses.
The approval includes a novel, 50 mg tablet, co-developed by MMV and GSK, that allows for accurate, weight-based dosing and can be dispersed in water to facilitate use for children. The current standard of care for treating children with P. vivax malaria in Brazil requires a 7-day course of treatment with a drug called primaquine and at present, there are no quality-assured, age-specific paediatric formulations available. Ensuring that children complete the full 7-day course of treatment and receive the correct dose are difficult challenges for parents, caregivers and health workers. If the correct course of treatment is not completed it is less effective, and the child will remain vulnerable to repeated relapses.
In Brazil over 40% of P. vivax and mixed infections last year were in children and young people below the age of 202. Children are especially vulnerable to severe disease, recurrence, and anaemia which affects their growth and development. With today’s approval, the door is open to extend this new treatment option to children from 2 years of age.
“MMV is proud to have co-developed single-dose tafenoquine with GSK, and we are thrilled to see the first malaria endemic country, Brazil, approve the use of this life-changing drug for children,” said Dr. David Reddy, CEO of MMV. “This child-friendly treatment can help put a stop to relentless P. vivax malaria relapses which are particularly dangerous for children.”
Brazil accounts for 27% of all malaria cases in the WHO Region of the Americas.3 P. vivax is the dominant parasite species in the country, responsible for 83% of reported malaria case in 2021.4 In June Brazil became the first malaria-endemic country to adopt tafenoquine into their National Health System for people aged 16 years and above. Tafenoquine represents a major breakthrough in the treatment of P. vivax malaria, as it is given in a single, convenient dose, making it easier for healthcare workers to administer and for patients to complete their treatment.
MMV and GSK are committed to ensuring that tafenoquine is made available to the millions of children affected by P. vivax malaria worldwide and have filed regulatory submissions in several endemic countries, with further submissions planned.
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Photo credit: Nathalie Brasil, Instagram: @_nathaliebl
1. Trademark owned or licensed by GSK.
2. Cases reported through the National Surveillance System for Malaria (SIVEP-MALARIA) in 2022: 110,580 autochtonous cases of P. vivax and mixed infections; of which 44,838 (40,5%) in people under 20 years of age.
3. WHO, World Malaria Report (2022), ‘three countries accounted for almost 80% of all estimated cases in the WHO Region of the Americas: Venezuela (Bolivarian Republic of) (34%), Brazil (27%) and Colombia (17%).’ https://www.who.int/teams/global-malaria-programme/reports/world-malaria-report-2022
4. Annex 4 – I. ‘Reported malaria cases by species, 2010-2021’, WHO, World Malaria Report (2022), ibid.