Kozenis/Krintafel

Trademarks owned or licensed by GSK
GSK

Product category	Product targeting prevention of relapse for P. vivax
Therapeutic indication	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 (to be approved country by 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, in Thailand in December 2019 and in Peru in January 2021 Under review in 4 endemic countries + additional 2 under ASEAN joint assessment procedure review
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