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US FDA AdComm Win For Aimmune’s Palforzia Bodes Well For DBV’s Peanut Allergy Patch

 
• By Sue Sutter

Aimmune’s oral immunotherapy seems destined to come to market with a strict REMS, though analysts do not expect this will impact adoption. DBV is awaiting word on whether the FDA will review its second attempt at a BLA submission for Viaskin Peanut.

Child's hand holding Peanuts, isolated on a white background. - Image
A US FDA panel endorsed the safety and efficacy of Palforzia for treating children with peanut allergies. • Source: Shutterstock

A US Food and Drug Administration panel’s positive review of Aimmune Therapeutics Inc.’s peanut allergy oral immunotherapy Palforzia would seem to bode well for DBV Technologies SA’s epicutaneous immunotherapy Viaskin Peanut, assuming the latter’s resubmitted application is up to snuff on manufacturing and the firm is prepared with a Risk Evaluation and Mitigation Strategy.

Although some analysts see the DBV patch product as having a more attractive safety profile than Aimmune’s Palforzia, the recent advisory committee review’s focus on a restrictive Risk Evaluation and Mitigation Strategy (REMS) for the oral

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