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Medicines for Malaria Venture (MMV) today announces that the Australian Therapeutic Goods Administration (TGA) has approved the use of single dose Kozenis (tafenoquine) in children aged 2 years and older in combination with chloroquine for the radical treatment (relapse prevention) of Plasmodium vivax (P. vivax) malaria.
The approval includes a new 50mg dispersible tablet which can be dispersed in water and which was developed by GSK in partnership with MMV to facilitate use in children, who are disproportionately affected by the disease.
“We are proud to have worked with GSK to develop this child-friendly treatment and are delighted with today’s announcement. P. vivax Malaria is particularly dangerous for young children, for whom repeated relapses can lead to cumulative severe anemia and, in some cases, be fatal. Today we have a tool to put an end to the relentless relapses for both adults and children – we are on the verge of defeating this disease. said Dr. David Reddy, CEO of MMV.
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Dr. Thomas Breuer, Chief Global Health Officer, GSK, said: “We are delighted with this approval of Kozenis for pediatric populations. This achievement is testament to the dedication of scientists at GSK and our partner MMV, who have all worked tirelessly to ensure that the first relapse prevention treatment for P. vivax malaria for over 60 years can be made available to the most vulnerable in society, our children.
The submission was supported by a Phase 2b clinical study (TEACH) that evaluated doses of tafenoquine by weight for children aged 2 years and weighing at least 10 kg and up to 15 years of age.
Kozenis is a single-dose treatment for the prevention of relapses of P. vivax and was approved for people aged 16 and over by the TGA in 2018. It should be used with a course of chloroquine to treat active blood stage infection, thereby achieving a drastic cure.
The current standard of care for the prevention of P. vivax relapse requires 7 or 14 days of treatment with a drug called primaquine, and at present there are no quality-assured, age-specific pediatric formulations on the market.
P vivax Malaria is estimated to cause between 4.1 and 5.1 million clinical infections each year and places a disproportionate burden on children aged 2 to 6 who are four times more likely than adults to be infected. The clinical characteristics of P. vivax malaria include fever, chills, vomiting, malaise, headache and muscle aches and in some cases can lead to severe malaria and death. P. vivax malaria infections also impact a child’s development and academic progress, with evidence showing that children who experience P. vivax infections are likely to suffer physical and cognitive impairment.
Further regulatory submissions are planned in malaria-endemic countries for pediatric indications of tafenoquine.
Tafenoquine, developed by GSK and MMV, was first approved by the US Food and Drug Administration for the radical treatment (relapse prevention) of P. vivax malaria in July 2018 for use in adults and adolescents ≥16 years of age. It was later approved by regulators in Australia, Brazil, Thailand and Peru.
Regulatory applications are progressing in other malaria-endemic countries. All approvals are based on efficacy and safety data from a comprehensive worldwide clinical development program for P vivax radical cure, conducted in nine malaria-endemic countries, which supported an overall positive risk-benefit profile for the use of the product.
Tafenoquine should be co-administered with chloroquine to treat both blood and liver stages of acute disease. P. vivax malarial infections (known as a radical cure). Before taking tafenoquine, patients should be tested for a deficiency in a specific enzyme called glucose-6-phosphate dehydrogenase (G6PD), which helps protect red blood cells. Patients with G6PD enzyme deficiency may experience serious adverse effects, such as hemolytic anemia, during treatment with the 8 aminoquinoline class (such as tafenoquine and primaquine) and only patients with G6PD enzyme activity > 70% of normal should receive tafenoquine.
P. vivax malaria has a significant health and economic impact, mainly in South Asia, Southeast Asia, Latin America and the Horn of Africa. the Plasmodium The parasite is a complex organism whose life cycle extends to both humans and mosquitoes. After a bite from an infected mosquito, the P. vivax parasite infects the blood and causes an acute episode of malaria. It also has the ability to lie dormant in the liver (in a form known as a hypnozoite), from where it periodically reactivates to cause relapses of P. vivax malaria. Therefore, a single P. vivax infection can give rise to multiple episodes of malaria in the absence of a new mosquito bite. These relapses can occur weeks, months or even years after the initial infection. Dormant hepatic forms of the parasite cannot be treated with most antimalarial treatments active against the blood-stage parasite.
Co-administration of a blood-stage antimalarial such as chloroquine and a drug targeting dormant hepatic forms of P. vivax parasite is known as the radical cure.