DBV Technologies Outlines Regulatory Path For Viaskin Peanut Allergy Patch For Kids Below 3 Years

DBV Technologies DBVT received written responses from the FDA on the regulatory path for the investigational Viaskin Peanut 250 μg patch (DBV712) in toddlers ages 1 – 3 years old with a confirmed peanut allergy.
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 intends to bring the safety database in 1–3-year-olds close to 600 patients on active treatment, which is consistent with the FDA's position supporting the company's dossier in 4–7-year-olds.
The safety study will not require a food challenge for study participation.
DBV plans to submit a proposed safety study protocol to the FDA by the end of Q2 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.
The company expects cash and cash equivalents of $192.3 million as of 31 March.
Price Action: DBVT shares are down 3.66% at $1.58 on the last check Thursday.