Kozenis/Krintafel

Trademarks owned or licensed by GSK
GSK

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Product category
  • Tafenoquine
Therapeutic indication

  • Radical cure (prevention of relapse) of P. vivax malaria
Dosing

  • Single-dose 300mg (adult) treatment
Efficacy

  • Phase lll 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

  • Under review in 4 endemic countries 
Next milestone

  • Complete study in combination with DHA-PQP and paediatric pharmacokinetic bridging study 

  • 1st endemic country approval and start of feasibility study
MMV Project Director
  • Elodie Jambert