GSK and Medicines for Malaria Venture (MMV) today announced that the Australian Therapeutic Goods Administration (TGA) has approved single-dose Kozenis (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for the acute P. vivax infection.

Anne Belcher, VP and General Manager GSK Australia, said: “We are delighted to have achieved approval for single-dose tafenoquine. In addition to providing a treatment option for P. vivax infected patients in Australia, the TGA approval of Kozenis will support regulatory submissions in P. vivax-endemic countries where there is significant unmet medical need for simple and effective therapies. Working with our partner, Medicines for Malaria Venture, our intent is to drive patient access in these countries by providing tafenoquine at an affordable price as part of global efforts to eradicate malaria.”

David Reddy, Chief Executive Officer of MMV said: “MMV wholeheartedly welcomes TGA’s approval of tafenoquine for the treatment of relapsing malaria. Together with the recent approval by the US FDA, Australia’s endorsement serves to underscore the importance and benefit of this important medicine to people debilitated by P. vivax malaria. Having worked closely with our partner GSK to get tafenoquine this far, we will lose no time in working with the regulatory authorities and National Malaria Control Programs in P. vivax-endemic countries to jointly get this transformative new single-dose cure to patients in need.”

The approval was based on efficacy and safety data from a comprehensive global clinical development programme for P. vivax radical cure which supported an overall positive benefit–risk profile for the proposed indication. 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). The results of the two phase III studies were announced in June 2017. The submission included data analysed from a total of thirty-three studies involving more than 4,000 trial subjects exposed to the 300mg single-dose and other doses of tafenoquine.

The decision by the TGA follows approval of tafenoquine (Krintafel) by the US Food and Drug Administration (FDA) on 20 July 2018. Approvals by the FDA and TGA will be informative to regulatory agencies in malaria-endemic countries for their own reviews. In these countries, tafenoquine will be provided at an affordable price to maximise access to those who need it most. Following TGA approval, GSK is planning for supply to Australia in 2019.