Aimmune to Submit FDA Application for Peanut OIT Candidate by End 2018


Aimmune Therapeutics presented its findings from the recent Phase III trial of AR101, their peanut oral immunotherapy candidate at the 2018 American Academy of Allergy, Asthma & Immunology–World Allergy Organization Joint Congress in Orlando. The company announced the topline results of the Phase III study entitled “PALISADE” in February.

Said Dr Stacie Jones, Professor and Chief of Pediatric Allergy and Immunology at the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital and a principal investigator of the Consortium of Food Allergy Research (CoFAR):

Dr Stacie JonesPhysicians, patients and their parents are eager for a treatment for peanut allergy, and this large-scale, multi-center study is a big step toward a potentially viable option. In PALISADE, we were delighted to see a relatively low-maintenance dose yield not only impressive gains in the amount of peanut protein tolerated, but also a very manageable tolerability and safety profile. Families will be excited to see these results that provide hope for them for a possible future treatment They want the potential of protection, and even a lessening of symptoms, due to accidental exposures to peanut in the real world.

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“The results of our Phase 3 PALISADE trial exceeded our expectations. Now, with positive data in hand, we are excited to intensify our efforts to deliver potentially the first approved treatment for peanut allergy,” said Aimmune CEO Dr Stephen Dilly.

Dilly announced the company would file a BLA – Biologics License Application – with the Food and Drug Administration (FDA) late this year. The BLA is a request for permission to introduce a biologic product into interstate commerce. Approval for a BLA generally takes in the neighborhood of eight to ten months, meaning if approved, AR101 could be offered as an FDA approved OIT therapy for peanut allergy in late 2019.

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