DBV Technologies announced that DBV has received written responses from the U.S. Food and Drug Administration (FDA) on the regulatory path for investigational Viaskin Peanut 250 µg patch (DBV712) in toddlers ages 1 – 3 years-old with a confirmed peanut allergy. In February 2023, DBV submitted a pre-BLA Meeting request to FDA. The Agency granted DBV's pre-BLA Meeting request as a written response only.

In the written responses received, the Agency confirmed that the Company's Phase 3 EPITOPE study met the pre-specified criteria for success for the 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 1 – 3-year-olds using the original Viaskin Peanut patch to augment the safety data collected from the Phase 3 EPITOPE study. The new safety study is intended to bring the safety database in 1–3-year-olds close to 600 patients on active treatment which is consistent with FDA's position in support of the Company's dossier in 4–7-year-olds.

The safety study will not require a food challenge for study participation. The new safety study will also generate patch adhesion data with updated Instructions for Use (IFU) that aligns with the methodology agreed with FDA for the VITESSE Phase 3 study. DBV is engaging with the FDA on critical design elements of the new safety study and plans to submit a proposed safety study protocol to the FDA by the end of Second Quarter 2023.

Viaskin Peanut in 1 – 3-year-olds (original patch) and Viaskin Peanut in 4 – 7-year-olds (modified patch) will continue as separate product candidates with independent clinical and regulatory paths. Additionally, DBV will conduct a Human Factors (HF) study of Viaskin Peanut to assess the user interface in the intended age group. DBV has conducted a preliminary, pilot HF validation study and will use the information generated as the basis for the final HF validation protocol, which will require FDA protocol review and alignment prior to initiation.

Concurrently, DBV continues to progress the Chemistry, Manufacturing, and Controls (CMC) sections of the BLA dossier.