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by Hospital Pharmacy Europe
Published on 28 July 2020

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First oral therapy for peanut allergy approved in the US

Palforzia, an oral immunotherapy to mitigate allergic reactions which includes anaphylaxis, caused by the accidental peanut exposure in patients with a confirmed peanut allergy has been approved by the FDA in the US.

The efficacy of the allergen powder was established in a randomised, double-blind trial with 496 children (aged 4 to 17 years) of which 372 received the allergen powder, were given a maintenance dose of 300mg/day (after a dose titration phase) for total of 24 weeks.

The primary outcome measure was the proportion of participants who could ingest a challenge dose of 600mg (roughly two peanuts) of peanut protein without dose-limiting symptoms at the trial end. A secondary outcome was the proportion of participants tolerating and 300 and 100mg dose also at the study end. The results showed that 62.7% of those given Palforzia tolerated a dose of 300mg of peanut protein with no more than mild symptoms, compared to 4% in the placebo group. For the secondary outcome, 76.6% and 50.3% tolerated a 300 and 100mg dose respectively compared with 8.1% and 2.4% in the placebo group.

Palforzia must be taken continuously and is indicted for children aged 4-17 years and in those 18 years and over. However, patients still need to practice allergy avoidance and carry an adrenalin injector.

Peanut allergen powder (Palforzia). JAMA 2020;324(2):192-3.

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