New malaria therapy for children gets first approval

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A new combination drug therapy against a type of malaria in kids aged 2 to 16 has received the first approval from Australian regulators.

The single dose tafenoquine (Kozenis), administered together with the standard chloroquine therapy, was developed by UK drug major GlaxoSmithKline (GSK) in partnership with nonprofit Medicines for Malaria Venture (MMV).

The approval includes a novel, 50 mg dispersible tablet that can be dispersed in water to fight malaria caused by pathogen Plasmodium vivax, which is most common in South and Southeast Asia, South America and the Horn of Africa. It is much simpler for kids to take than the present seven- or 14-day course of tablets developed for adults.

“P. vivax malaria is particularly dangerous for young children for whom repeated relapses can lead to cumulative severe anaemia and, in some cases, be fatal. Today, we have a tool to put a stop to the relentless relapse both for adults and children – we are one step closer to defeating this disease,” said Dr David Reddy, Chief Executive Officer, MMV, in a statement.

Tafenoquine will be submitted for approval in nine nations, in addition to the World Well being Group, George Jagoe, Executive Vice President Access & Product Management, at MMV was quoted as saying to the New York Times.

Malaria is among the many deadliest of infectious ailments. In 2019, there were 229 million new infections and 558,000 deaths. But during the Covid-19 pandemic the numbers rose to 627,000 deaths in 2020.

Infection due to P. vivax is estimated to cause between 4.1 and 5.1 million clinical infections every year, and poses a disproportionate burden for children aged 2 to 6 years who are four times as likely as adults to be infected.

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.

P. vivax may conceal itself within the liver, triggering relapses months and even years after the preliminary publicity. These episodes can result in extreme anemia, lasting mind harm and loss of life.

Most therapies, together with chloroquine, are directed on the blood stage of the parasite, and so can’t stop recurrence of the an infection and its related signs. However tafenoquine goes after the sleeper colonies within the liver. Together with chloroquine, tafenoquine can ship what scientists name a “radical remedy”, the NYT reported.

The approval was based on a study of 60 kids aged 2 to 15, with P. vivax malaria from three websites in Vietnam and one in Colombia.

After being administered a single dose of tafenoquine and a course of chloroquine, about 62 per cent of the kids reported some negative effects, a share just like that seen in adults and adolescents, the researchers reported. Not one of the negative effects have been extreme, though the therapy precipitated vomiting in about one in 5 of the youngsters.

At 4 months, the efficacy of the therapy in stopping recurrence was 95 per cent, just like the efficacy in adults and older adolescents, the report said.

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