In an­oth­er win for ri­val Aim­mune, FDA press­es pause on DB­V's peanut patch with ad­di­tion­al ques­tions

An­oth­er reg­u­la­to­ry set­back has strayed DBV Ther­a­peu­tics’s peanut al­ler­gy patch off the path to ap­proval.

On Mon­day, the com­pa­ny dis­closed that the FDA, which is cur­rent­ly re­view­ing the mar­ket­ing ap­pli­ca­tion for the patch, had ques­tions re­gard­ing the patch’s ad­he­sion and ef­fi­ca­cy con­cerns if the patch was not ful­ly ad­hered to the pa­tient’s skin. Con­se­quent­ly, the FDA ad­vi­so­ry com­mit­tee meet­ing sched­uled for May 15 will not be tak­ing place — al­though no changes to the FDA’s ac­tion date of Au­gust 5 were an­nounced.

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