Kozenis or Krintafel

Trademarks owned or licensed by GSK
GSK

Product category
  • Product targeting prevention of relapse for P. vivax
Therapeutic indication
  • Use in combination with chloroquine for the prevention of relapse of P. vivax malaria from 16 years of age
Dosing
  • Single-dose 300 mg (2 adult tablets of 150 mg) treatment of tafenoquine (TQ)

Efficacy
  • Phase III data confirms 62% recurrence-free efficacy (relapses and new infections) at 6 months post treatment when used with chloroquine

Key features
  • Single-dose treatment to prevent relapse of P. vivax malaria

  • 3-year shelf life (to be approved country by country)
Challenges
  • Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD)  deficiency required, as product is contraindicated in G6PD deficiency
  • Not for use in combination with ACTs for the prevention of relapse of P. vivax
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
  • TRust feasability study in Brazil initiated
  • Under review in six endemic countries including two following subsequent 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 by end of Q3 2022
  • Second interim analysis from the TRuST feasibility study in Brazil expected by end Q3 2022; start of ARCTIC feasibility study in Thailand, in conjunction with quantitative G6PD testing expected in Q2 2022
MMV Project Director
  • Dr Elodie Jambert