Tafenoquine for radical cure of P. vivax malariaSeptember 14, 2018
The US FDA granted approval for single-dose tafenoquine (Krintafel) for the radical cure of Plasmodium vivax malaria in patients aged 16 years and older, GSK and Medicines for Malaria Venture (MMV) said.
Tafenoquine is the first new treatment for P. vivax malaria in over 60 years.
Tafenoquine is an 8-aminoquinoline derivative with activity against all stages of the P. vivax lifecycle, including hypnozoites.
It was first synthesised by scientists at the Walter Reed Army Institute of Research in 1978.
In 2008, GSK entered into a collaboration with the not-for-profit drug research partnership, MMV, to develop tafenoquine as an anti-relapse medicine for patients infected with P. vivax.
The approval was based on efficacy and safety data from a comprehensive global clinical development P. vivax radical cure programme designed in agreement with the FDA. Thirteen studies in healthy volunteers and patients directly supported the programme. The primary evidence for the clinical efficacy and safety of the 300mg single-dose, to which more than 800 subjects were exposed, was provided by three randomised, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564).