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 desensitization process and were outweighed by the benefits, as long as Aimmune Therapeutics Inc. (NASDAQ:AIMT) and FDA expand the proposed REMS...