GlaxoSmithKline (GSK) has gained the US Food and Drug Administration (FDA) priority review approval for its Krintafel (tafenoquine) to prevent malaria relapse caused by Plasmodium vivax (P. vivax).
The indication covers s single-dose of the drug in patients aged 16 years and above who are receiving anti-malarial therapy for acute P. vivax infection.
An eight-aminoquinoline derivative, Krintafel is said to possess activity against all P. vivax lifecycle stages, including hypnozoites.
The drug was initially synthesised in 1978 by the Walter Reed Army Institute of Research scientists. Later, GSK started research and development for tafenoquine to potentially treat malaria.
GSK partnered with non-profit drug research organisation Medicines for Malaria Venture (MMV) in 2008 to further advance tafenoquine as an anti-relapse drug for P. vivax infected patients.
Following the FDA approval, Krintafel is now considered as to be the first single-dose medicine to counter P. vivax malaria relapse.
GSK chief scientific officer and Research and Development president Hal Barron said: “Today’s approval of Krintafel, the first new treatment for Plasmodium vivax malaria in over 60 years, is a significant milestone for people living with this type of relapsing malaria.
“Together with our partner, Medicines for Malaria Venture, we believe Krintafel will be an important medicine for patients with malaria and contribute to the ongoing effort to eradicate this disease.”
MMV chief executive officer Dr. David Reddy said: “The US FDA’s approval of Krintafel is a major milestone and a significant contribution towards global efforts to eradicate malaria. The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance.
“We are proud to have worked side-by-side with GSK for more than a decade to reach this point. Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most.”
The regulator’s decision is said to be based on safety and efficacy results obtained during a global clinical development P. vivax radical cure programme that involved 13 clinical trials in both healthy participants and patients.
Primary evidence for the clinical efficacy and safety of 300mg single-dose tafenoquine comes from analysis of more than 800 subjects in randomised, double-blind DETECTIVE Part 1 and Part 2 and GATHER studies.