DBV Aligns With FDA On Accelerated Approval For Viaskin Peanut Patch In Younger Kids

On Wednesday, DBV Technologies SA DBVT reached a significant milestone with the FDA regarding its Viaskin Peanut patch for toddlers aged 1–3 years.

The FDA has outlined a clear Accelerated Approval pathway for the therapy, offering a streamlined regulatory process for peanut allergy treatment.

The FDA confirmed that the Viaskin Peanut patch satisfies the key criteria for Accelerated Approval, including addressing a serious condition and offering a meaningful advantage over existing therapies.

The FDA also acknowledged that efficacy data from DBV's Phase 3 EPITOPE study meets the requirement of an intermediate clinical endpoint reasonably predicting clinical benefits.

The pivotal decision reduces regulatory uncertainty and allows DBV to concentrate on completing essential studies.

To meet FDA requirements for Accelerated Approval, DBV will conduct a post-marketing confirmatory study using the commercial version of the Viaskin Peanut patch.

This study will validate the safety and efficacy of the redesigned patch, which features improvements for ease of use and identification without altering skin contact components. The confirmatory study will include a double-blind, placebo-controlled food challenge and aims to support the Biologic License Application (BLA) for toddlers aged 1–3 years.

The ongoing COMFORT Toddlers trial will complement these efforts.

This Phase 3 study will evaluate safety, adhesion, and efficacy in approximately 480 participants across multiple regions. Data from this study will be crucial in DBV's FDA marketing application submission, expected in the second half of 2026.

DBV has initiated study start-up activities and plans to screen the first subject in the second quarter of 2025.

Price Action: DBVT stock is up 14.90% at $3.78 at the last check on Thursday.

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