DBV Technologies Updates on Viaskin Peanut Patch BLA Submission Progress
DBV Technologies provided an update on the biologics license application, or BLA, submission seeking marketing approval of the Viaskin Peanut Patch in children aged four through seven years. Over recent weeks, DBV has had ongoing detailed and iterative engagement with the FDA with the objective of ensuring a review of the company's upcoming BLA for children aged four through seven years. DBV and the FDA have collaborated through meetings, information exchanges, and filings for the Viaskin Peanut Patch investigational new drug application, or IND. Through this process and based on its review, DBV received input from the FDA, specific to the organization, mapping, and formatting of existing data sets for the CMC and biostatistical elements of the BLA. The FDA has not requested additional data. The company will take the required time to incorporate that feedback and now anticipates filing of the BLA to occur in the third quarter of 2026.
