Krintafel/Kozenis

Trademarks owned or licensed by GSK
GSK

Product category
  • Tafenoquine
Product vision
  • Anti-relapse therapy for P. vivax malaria

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 paediatric PK bridging study

  • Brazil registration decision in 2019 (adult dosage form) 

MMV Project Director
  • Dr Isabelle Borghini