Friday , June 18 2021

The new drug may announce a "change of the sea" in the treatment of food allergies The Berkeley Eagle

From Caroline J. Johnson, Washington Post

A large study provides the strongest evidence that children and teenagers can be desensitized to peanut allergens through controlled, escalating exposure to a substance that could otherwise cause a life-threatening reaction – advances that specialists have said would likely signal the development of a new food allergy drugs.

After one year of treatment with an experimental drug made by Aimmune Therapeutics, 67 per cent of children and teenagers with peanut allergens could safely insert the equivalent of at least two peanuts, compared with only 4 per cent of those on placebo, according to a study published in New England Journal of Medicine. But this improvement came at a price – almost all participants in the study who received the drug, pharmaceutical-grade preparation of peanut flour, experienced adverse events of some type, and one in 10 withdrew from the examination due to gastrointestinal, skin or respiratory problems, or systemic allergic reactions.

For years, smaller studies have suggested that exposure to escalating amounts of peanut allergens could desensitize people to potentially life-threatening effects of exposure, which may include anaphylactic shock, but several external experts say a large, systematic study of 550 people could lead to the first treatment approved by the Food and Drug Administration. The majority of participants were between the ages of 4 and 17, the group in which researchers consider the drug to be effective.

"I think that from now on, we are looking to go where there is no approved food allergy treatment, a landscape where we will probably have several options in a few years to offer our patients," said Corinne Keith, a pediatric allergist at the Medical a faculty in Johns Hopkins, who did not take part in the study, and who said it would mean "changing the sea" given the lack of options today. "In the short term, products that can come on the market are not being treated, but I think there are several different approaches that are exploring – and in general, the goal is more healing treatment."

Aimmune, who funded the study, plans to file a drug application to federal regulators next month and predicts it could begin in late 2019. It's not clear how much it will cost, how long patients will need to take it, and whether it would be covered by insurance.

"For now, the council will be for ongoing treatment," said Wayne Schreefler, director of the Food Allergy Center at the Massachusetts General Hospital, and one of the authors of the study, who received trial funding and benefits from Aymun. "Further studies will be required to decide whether a few years later some people can change their regular dosing. The vast majority of participants in the study tolerated treatment and expect the same to apply to its use in the" real world "when and if it is approved ".

Treatment is not a cure, and the regime can not appeal to anyone with food allergies. Patients came to the clinic every two weeks to gradually increase their dose under surveillance for a period of six months. They also took drugs at home everyday.

"I think it's important to remember what the purpose of this treatment is – the goal is not to allow people to eat peanuts freely," said Daniel Adelman, chief medical officer of Aimon. "Children go out to the door every morning, and their parents are worried, this is the day when they are exposed to peanuts and will potentially have a life-threatening reaction, the purpose of this treatment is to help protect people from potentially life-threatening reactions" .

Aimmune will expand access to other food allergies, testing whether similar drugs could work to desensitize children to allergy to eggs next year.

Experts warn that this type of regime should not be started at home.

There are approximately 6 million children with food allergies in the United States. In the accompanying newsroom, Michael Perkin, of the University of London's Population Health Research Institute, noted that the potential market for therapy is billions of dollars. The Aimmune drug was a skimmed peanut flour made through the rigorous production processes required for pharmaceutical products, which Adelman stressed meant that it was free from the variability that could pose the danger of delivering the wrong dose.

Keet said one concern was whether parents and children would understand the boundaries of the drug.

"We still require patients to review the labels and not import anything with peanuts in them," Keith said. "We do not know what people will do with this partial protection – it can give people a false sense of security."

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