Acceptance to review the paediatric dossier by the Australian drug regulator is an important and big step towards making this medicine available to the children that need it
GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.
The application includes data for a new, 50 mg tablet that can be dispersed in water and which was developed to facilitate use in children, who are disproportionately affected by the disease.
The submission is supported by a Phase 2b clinical study (TEACH) that evaluated dosages of tafenoquine based on weight for children between the age of 6 months and weighing at least 5 kg, up to 15 years.
Kozenis is a single-dose treatment for the radical cure (prevention of relapse) of P. vivax and was approved for people aged 16 years and older by the TGA in 2018. It should be used with a course of chloroquine to treat the active blood-stage infection.
The current standard of care for prevention of P. vivax relapse requires a 14-day course of treatment and at present there is no age-specific paediatric formulation.
P. vivax malaria is estimated to cause around 6.4 million clinical infections every year, and children are four times as likely as adults to be affected.1,2 The clinical features of P. vivax malaria include fever, chills, vomiting, malaise, headache and muscle pain, and in some cases, can lead to severe malaria and death.3 The prevalence of P. vivax peaks in children aged 2-6 years old.4
Further regulatory submissions for a paediatric indication for tafenoquine are planned in malaria-endemic countries.
“Great news for the new year! Australia’s drug regulator has accepted to review our child-friendly medicine for malaria relapse prevention – a big step towards making this medicine available to the children that need it,” said Dr David Reddy, CEO of MMV. “We at MMV are proud to have worked side-by-side with GSK for more than a decade to develop this medicine and a special formulation for children, who suffer disproportionately from malaria.”