Kozenis/Krintafel

Trademarks owned or licensed by GSK
GSK

Product category	Product targeting prevention of relapse for P. vivax Uncomplicated malaria treatment for single-exposure radical cure (SERC) and/or resistance management
Therapeutic indication	Radical cure (prevention of relapse) of P. vivax malaria from 16 years of age
Dosing	Single-dose 300mg (adult) treatment of tafenoquine (TQ)
Efficacy	Phase III data confirms 62% recurrence-free (relapses + new infections) at 6 months post treatment when used with chloroquine Low efficacy when used with dihydroartemisinin-piperaquine (DHA-PQP)
Key features	Single-dose treatment to prevent relapse of P. vivax malaria Two to three-year shelf life (depending on country)
Challenges	Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD) deficiency required, as contraindicated in G6PD deficiency No quantitative G6PD test has been prequalified or approved by a stringent regulatory agency yet
Status	Approved by US FDA July 2018 and by Australian TGA September 2018 Approved in first malaria-endemic country (Brazil) in October 2019 and in Thailand in December 2019 Under review in 5 endemic countries
Next milestone	Pharmacokinetic results expected for the INSPECTOR study, assessing safety and efficacy of TQ in combination with DHA-PQP Start of feasibility study in Brazil and in Thailand, in conjunction with quantitative G6PD testing
MMV Project Director	Elodie Jambert