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