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
  • Tafenoquine
Therapeutic indication
  • Radical cure (prevention of relapse) of P. vivax malaria from 16 years of age

Dosing
  • Single-dose 300mg (adult) treatment

Efficacy
  • Phase III data confirms 62% recurrence-free (relapses + new infections) at 6 months post treatment

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

  • Contraindicated in G6PD deficiency
Challenges
  • Quantitative testing for G6PD deficiency required; SRA (US) filing of G6PD test (by PATH)
  • Clarity around continued role for primaquine (G6PD-deficient patients)
Status
  • Approved by US FDA July 2018 and by Australian TGA September 2018
  • Approved in first malaria-endemic country (Brazil) by ANVISA in October 2019
  • Under review in 4 endemic countries
Next milestone
  • Complete paediatric pharmacokinetic bridging study
  • Full study outputs including pharmacokinetics expected for the study in combination with DHA-PQP
  • Start of feasibility study in Brazil, in conjunction with quantitative G6PD testing
MMV Project Director
  • Elodie Jambert