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 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

  • Clarity around continued role for primaquine (G6PD-deficient patients)
Status

  • Approved by US FDA July 2018 and by Australian TGA September 2018

  • Brazil ANVISA submission under review 
Next milestone

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

  • 1st endemic country (Brazil) approval

  • SRA (US) filing of G6PD test (PATH)
MMV Project Director
  • Dr Isabelle Borghini