Tafenoquine

Single-exposure cure

Rithsankan Kea Kim lives with his wife and two sons in Oslev, a small mountain village in Cambodia, close to the Thai border. He farms soya beans for a living. In 2014, he suffered from malaria five times; twice it was caused by P. vivax and three times it was a mixed infection. “I feel pain in my whole body, in my bones too,” said Rithsankan.
 

Kozenis/Krintafel

Trademarks owned or licensed by GSK
GSK

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

Developing a single-exposure cure to stop the relapse

Tafenoquine is in phase III development with GSK. The aim is to investigate its potential as a single-exposure medicine to prevent the relapse of P. vivax malaria, with the current intention of submitting a new drug application to the US FDA1 in 2017. If successful, it would be the first new medicine for relapsing malaria to progress to regulatory approval in over 60 years. Tafenoquine would be used alongside a blood-stage medicine, which together would cure the current malaria infection and prevent a future relapse.

MMV Project of the Year award 2013 - Tafenoquine

Tafenoquine, a potential nextgeneration anti-relapse medicine for P. vivax malaria, successfully completed a Phase IIB trial in 2013. In that trial, a 300 mg single dose of tafenoquine plus chloroquine provided better protection from P. vivax relapse than chloroquine alone. In addition, the US FDA granted tafenoquine Breakthrough Therapy designation – one of its newest initiatives aimed to accelerate the development and review times of drugs for serious or life-threatening diseases.

GSK and MMV announce start of Phase III programme of tafenoquine

GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) today announced the start of a phase III global programme to evaluate the efficacy and safety of tafenoquine, an investigational medicine which is being developed for the treatment and relapse prevention (radical cure) of Plasmodium vivax (P. vivax) malaria.

Breakthrough Therapy designation for potential new anti-relapse medicine for malaria

GlaxoSmithKline (GSK) and Medicines for Malaria Venture (MMV) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation* for tafenoquine, an investigational medicine for the treatment and relapse prevention of Plasmodium vivax malaria. Tafenoquine is not yet approved or licensed for use anywhere in the world. Breakthrough Therapy designation is the newest of the FDA’s programmes aimed at accelerating the development and review times of drugs for serious or life-threatening conditions.

A step closer to stopping the relapse

Tafenoquine, a potential next-generation anti-relapse medicine for P. vivax malaria, successfully completed a Phase IIB trial in 2013. In that trial, a 300 mg single dose of tafenoquine plus chloroquine provided better protection from P. vivax relapse than chloroquine alone.

Pages

Subscribe to RSS - Tafenoquine