FDA panel backs Aimmune’s peanut allergy therapy, wants expanded REMS

Despite concerns over a new surrogate endpoint and increased risk of allergic reactions, the very thing the treatment is designed to diminish, an FDA advisory panel voted 7-2 in favor of the efficacy of Aimmune’s Palforzia in reducing the incidence and severity of allergic reactions following accidental peanut exposure in patients aged 4-17.

Those reactions, the Allergenic Products Advisory Committee concluded, were an anticipated part of the oral immunotherapy’s allergen

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