No sur­pris­es in FDA staff re­view for Aim­mune peanut al­ler­gy ther­a­py — fo­cus re­mains on safe­ty, tol­er­a­bil­i­ty pro­file

Ahead of the keen­ly an­tic­i­pat­ed in­de­pen­dent pan­el set to dis­cuss Aim­mune’s peanut al­ler­gy im­munother­a­py on Fri­day, FDA staff is­sued a pre­dictable re­view on Wednes­day, high­light­ing the po­ten­tial safe­ty and tol­er­a­bil­i­ty is­sues as­so­ci­at­ed with the prod­uct, while back­ing its ef­fi­ca­cy.

Tra­di­tion­al­ly, peanut al­ler­gies are man­aged by avoid­ance, but the threat of ac­ci­den­tal ex­po­sure can­not be nul­li­fied. In the Unit­ed States, da­ta sug­gest peanut al­ler­gies af­fect an es­ti­mat­ed 1.2% of the to­tal pop­u­la­tion — this is the mar­ket Aim­mune is itch­ing to ad­dress with its im­munother­a­py.

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