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# DBV Tech Gets FDA Input in pre-BLA Meeting
- URL: https://www.fdaweb.com/dbv-tech-gets-fda-input-in-pre-bla-meeting/
- Published: 2023-04-20T12:00:00.000Z
- Updated: 2026-09-14T18:26:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154268

DBV Technologies has received written responses from FDA after a pre-BLA meeting in February about the regulatory path for investigational Viaskin Peanut 250 μg patch (DBV712) for use in toddlers with a confirmed peanut allergy. The French biotech company says the agency granted its meeting request on a written response only basis and confirmed that its Phase 3 EPITOPE study met the pre-specified criteria for a successful primary endpoint. “The FDA did not request an additional efficacy study to support a future BLA but requires that DBV conduct an additional safety study in one-to-three year olds using the original Viaskin Peanut patch to augment the safety data collected from the Phase 3 EPITOPE study,” DBV says.

Additionally, the safety study will provide patch adhesion data with updated “Instructions for Use.” DBV says it will work with the agency on the study’s critical design elements and will submit a proposed safety study protocol by 6/31.