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Peanut allergy treatment ready for FDA review

22 November 2018
Peanut allergy treatment ready for FDA review

A new study published today involving 30 Irish children reveals that giving them controlled doses of a form of peanut flour over time can build up their tolerance to the food that might otherwise trigger a fatal reaction.

However, the discovery is revolutionary because the study reports that there are now no approved treatment options for patients who are at risk for unpredictable and life-threatening allergic reactions to peanuts. If this treatment is approved by the FDA, it will be available by prescription, and people with peanut allergy will need to remain on it to stay protected against accidental consumption.

Qualifying participants started with a one-day supervised increase in dosage from 0.5 mg of peanut protein up to 6 mg, an increase every two weeks from 3 mg to 240 mg and a 24-week "maintenance phase" at 300 mg.

Aimmune, which funded the study, plans to submit an application for the drug to federal regulators next month and anticipates it could launch in late 2019.

Peanut vs peanut " We're excited about the potential to help children and adolescents with peanut allergy protect themselves against accidentally eating a food with peanut in it", says co-author Stephen Tilles, MD.

Professor George du Toit, paediatric allergy consultant at Evelina London and the study's chief investigator, said: "Peanut allergy is extremely hard to manage for children and their families, as they have to follow a strict peanut-free diet".

Food Allergy Research & Education (FARE) has more on peanut allergy.

Within the active-drug group, 67.2 percent of children were able to ingest 600 milligrams of peanut protein, compared to just four percent of the placebo group.

"This is not a quick fix, and it doesn't mean people with peanut allergy will be able to eat peanuts whenever they want", says allergist Jay Lieberman, MD, vice chair of the ACAAI Food Allergy Committee and study co-author.

However, according to Christina Ciaccio, Associate Professor from the University of Chicago in the United States, the drug "is not a quick fix, and it doesn't mean people with peanut allergy will be able to eat peanuts whenever they want". But, much like the study on families with high socioeconomic status, the drug was most effective in younger participants, with those aged 18 to 55 years not experiencing significant results. A majority of the participants had a history of anaphylaxis, a severe and life-threatening allergic reaction. They account for the majority of deaths related to food allergy.

Adverse events were common in the two trial groups.