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After one year of treatment with an experimental drug manufactured by Aimmune Therapeutics, 67% of peanut-allergic children and adolescents were able to safely ingest the equivalent of at least two peanuts, compared to 4% of those taking placebo , according to the published study. in the New England Journal of Medicine. But this improvement came at a cost: almost all of the study participants receiving the drug, a pharmaceutical-grade peanut meal preparation, experienced a type of adverse event and one in ten withdrew from the test because of gastrointestinal, respiratory or respiratory disorders. systemic problems or allergic reactions.
For years, small studies have suggested that exposure to increasing amounts of peanut allergen could desensitize people to potentially lethal effects of exposure, which may include anaphylactic shock , but several outside experts said the extensive systematic study conducted at 550 people could at the first treatment approved by the Food and Drug Administration. The majority of participants were aged 4 to 17, the group in which the researchers found the drug effective.
"I think we're thinking of going from here where there is no approved treatment for food allergy, to a landscape in which we will probably have a few options to offer our patients," said Corinne Allison Keet, a pediatric allergist from the Johns Hopkins School of Medicine who did not participate in the study and who stated that this would be a "radical change" given the current shortage of options. "In the short term, products likely to be on the market are not cures, but I think different approaches are being explored – and overall, the goal is more of a cure. . "
Aimmune, which funded the study, plans to submit a drug application to the federal regulators next month and plans to launch it by the end of 2019. It is unclear how much it would cost, how long patients should take it. and if would be covered by insurance.
"For now, the advice will be on current treatment," said Wayne G. Shreffler, director of the Food Allergy Center at Massachusetts General Hospital and one of the authors of the study who received trial funding. and a fee from Aimmune. "Further studies will be needed to determine if, after a few years, some people may change the usual dosage. The vast majority of study participants have tolerated the treatment, and I hope this will also be the case for its use in the real world when and if it is approved. "
The treatment is not a cure, and the diet may not appeal to all people with food allergies. Patients visited a clinic every two weeks to see their dose gradually increase under supervision over a six-month period. They also took the medicine home every day.
"I think it's important to remember the purpose of this treatment.The goal is not to allow people to eat peanuts at will," said Daniel Adelman, Chief Medical Officer at Aimmune. "The children come out every morning and their parents worry. This is the day they will be exposed to peanuts and risk their lives. The purpose of this treatment is to help protect people against these potentially life-threatening reactions. "
Aimmune will expand its approach to other food allergies, checking if a similar drug could help desensitize children to egg allergies next year.
Experts have warned that this type of diet should not be started at home.
In the United States, an estimated 6 million children are suffering from food allergies. In an accompanying editorial, Michael R. Perkin, of the Institute of Population Health Research at the University of London, St. George's, pointed out that the potential market for A therapy is several billion dollars. Aimmune was a defatted peanut flour manufactured according to the rigorous manufacturing processes required for pharmaceuticals. Adelman pointed out that it was free of variability that could result in the risk of delivering the wrong dose.
Keet said that one of the concerns was whether parents and children would understand the limitations of the drug.
"We would always ask patients to examine the labels and not eat peanuts," said Keet. "We do not know what people would end up doing with this partial protection – it could give people a false sense of security."
The Aimmune action closed 11% on Monday.
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