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.
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.
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.
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.
The results of the Phase IIb study investigating tafenoquine plus 3 days of chloroquine for the treatment and prevention of Plasmodium vivax (relapsing) malaria have been published today in The Lancet.1Tafenoquine is in development with GSK and MMV.
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.
Primaquine is the only medicine approved for the radical cure of relapsing Plasmodium vivax malaria. However, the drug can lead to hemolytic anemia in recipients who are deficient in an enzyme, glucose 6-phosphate dehydrogenase (G6PD). Genetic deficiency in G6PD occurs in over 400 million people, most of whom are located in malaria-endemic regions.
In collaboration with MMV, GSK is evaluating the safety and efficacy of tafenoquine, the lead investigational medicine for the treatment of P. vivax (relapsing) malaria. This phase IIb clinical trial spans four malaria-endemic countries: Thailand, India, Peru and Brazil – the first Peruvian patients were recruited in September 2011 and the first Brazilian patients last week.