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DBV Pulls EU Peanut Allergy Patch Filing To Work On A Stronger Application

 
• By Neena Brizmohun

Following regulatory setbacks in the US and also now in the EU, DBV Technologies is to conduct a new pivotal trial of a modified version of its peanut allergy patch to support its efforts to win marketing approval.

Peanut allergy. Conceptual image.
DBV's patch is for treating peanut allergy in children • Source: Alamy

DBV Technologies has withdrawn its EU marketing authorization application (MAA) for Viaskin Peanut (Arachis hypogaea extract), an investigational patch for peanut allergy in children that was rejected for marketing in the US in 2020.

The company withdrew the MAA after learning from the European Medicines Agency that the trial data it used in the filing would not be sufficient to preclude a major objection...

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