Groundbreaking Treatment That Reduces Severity Of Peanut Allergies Heads Toward FDA Approval

Henrietta Brewer
November 22, 2018

By its end, about two in three of the almost 400 children being given the drug (whose dosage was increased as the study went on) were able to take in 600 milligrams of peanut protein without having an allergic reaction. But they also cautioned that the treatment does not cure peanut allergies and should not be attempted at home.

He said: "Up to now, without any treatment available, peanut allergy has put children and adults at risk of unpredictable and occasionally life-threatening reactions".

"Kids go out the door every morning, and their parents worry, this is the day they'll be exposed to peanuts and potentially have a life-threatening reaction".

'Her allergy was very severe so even a small amount of peanut could lead to a very serious reaction'. He brought his own cupcake to school birthday parties, learned to read food labels and turned 15 without ever tasting a Kit Kat, Twix or Three Musketeers bar, all of which may contain traces of peanut because they are made in facilities that process the nuts.

During the study, participants were split into groups and given either a capsule of peanut protein or a dummy powder. OFCs are considered the gold standard for testing food allergy.

Aimmune Therapeutics (NASDAQ:AIMT) is up 6% premarket, albeit on only 800 shares, on the heels of the publication in the New England Journal of Medicine of results from the Phase 3 PALISADE study evaluating AR101 in patients with peanut allergy.

"Reactions from the oral challenges at the end of the study were much milder than prior to treatment", says Dr. Tilles.

- 80 percent of participants successfully reached daily maintenance dose of the equivalent of one peanut.

"On average, the participants were able to tolerate a 100-fold higher dose of peanut at the end of the study than they did at the beginning". More than 11 percent of children dropped out of the study due to adverse symptoms, and almost all of the children-even those in the AR101 group-had an adverse event during the trial period.

Almost 500 children aged four to 17 from across the United States and Europe took part in the trial - known as the Palisade study - making it the largest-ever peanut allergy treatment trial. It will be available by prescription, and patients will need to remain on it to stay protected against accidental consumption.

The outcomes declared at a convention of the American College of Allergy, Asthma & Immunology in Seattle, may conduct to acceptance of what could be the premiere oral medication that reform responses to children with excruciating peanut allergies.

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