TGA approves single-dose Kozenis for children with P.vivax malaria
The approval includes a novel, 50 mg tablet that can be dispersed in water, which was developed by GSK in partnership with MMV to facilitate use in children, who are disproportionately affected by the disease
Medicines for Malaria Venture (MMV) yesterday announced that the Australian Therapeutic Goods Administration (TGA) has approved the use of single-dose Kozenis (tafenoquine) in children aged two years and above in combination with chloroquine for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.
The approval includes a novel, 50 mg tablet that can be dispersed in water, which was developed by GSK in partnership with MMV to facilitate use in children, who are disproportionately affected by the disease.
The submission was supported by a phase-IIb clinical study (TEACH) that evaluated dosages of tafenoquine based on weight for children between the age of two years, and weighing at least 10 kg, and up to 15 years.
Kozenis is a single-dose treatment for the 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, thereby achieving radical cure.
The current standard of care for prevention of P. vivax relapse requires a seven- or 14-day course of treatment with a drug called primaquine, and, at present, there are no quality-assured, age-specific paediatric formulations marketed.
Further regulatory submissions are planned in malaria-endemic countries for paediatric indications for tafenoquine.
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