DBV Technologies Files FDA Biologics License Application for Peanut Patch
DBV Technologies has submitted a Biologics License Application to the U.S. FDA for its Viaskin Peanut patch targeting children aged 4 to 7.
DBV Technologies announced Monday it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval of its Viaskin Peanut patch for children between the ages of 4 and 7, a milestone the French biotech company said marks a critical step toward bringing an epicutaneous immunotherapy option to young peanut-allergy patients.
The Viaskin Peanut patch is designed to desensitize children to peanut proteins through skin-based delivery, an approach known as epicutaneous immunotherapy. The therapy aims to reduce the risk of severe allergic reactions in a population for whom accidental peanut exposure can be life-threatening.
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The BLA submission to the FDA initiates a formal regulatory review process that, if successful, could result in the first approved patch-based treatment for peanut allergy in young children in the United States. Regulatory decisions of this nature typically involve a standard review period, during which the agency evaluates clinical safety and efficacy data.
DBV Technologies, headquartered in Châtillon, France, has focused its pipeline on allergy immunotherapy and has faced a lengthy regulatory path with the Viaskin program, including prior interactions with the FDA over manufacturing and clinical data. The BLA filing signals the company believes those issues have been sufficiently addressed to support a complete submission.
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