Kozenis/Krintafel

Trademarks owned or licensed by GSK
GSK

Product category
  • Product targeting prevention of relapse for P. vivax
Therapeutic indication
  • Prevention of relapse of P. vivax malaria from 16 years of age

Dosing
  • Single-dose 300mg (adult) treatment of tafenoquine (TQ)

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

  • Low efficacy when used with dihydroartemisinin-piperaquine (DHA-PQP)

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

  • Two to three-year shelf life (to be approved country by country)
Challenges
  • Quantitative testing for glucose-6-phosphate dehydrogenase (G6PD)  deficiency required, as contraindicated in G6PD deficiency
  • No quantitative G6PD test has been prequalified or approved by a stringent regulatory agency yet
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
  • Under review in 4 endemic countries + additional 2 under 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
  • Start of feasibility study in Brazil and in Thailand, in conjunction with quantitative G6PD testing
MMV Project Director
  • Elodie Jambert