DBV Technologies' Viaskin Peanut patch has shown promising results in treating peanut allergies in toddlers, with the FDA outlining a clear Accelerated Approval pathway for the therapy. This offers 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.
EPITOPE Trial Extension Shows Sustained Improvement
Data from the Open-Label Extension (OLE) study of EPITOPE demonstrated continued improvement in treatment benefit with Viaskin Peanut over 36 months in toddlers aged 1-3 years. Key highlights include:
- 83.5% of participants reached an eliciting dose (ED) of ≥1000 mg after three years, an increase from 64.2% at month 12.
- 68.2% of subjects completed the oral food challenge without meeting stopping criteria, compared to 30.7% at month 12.
- Continued reductions in DBPCFC reaction severity occurred, with 66.5% having no/mild symptoms at month 36 vs 40.2% at month 12.
- No treatment-related anaphylaxis or serious treatment-related Treatment-Emergent Adverse Events (TEAEs) occurred in year three.
Pharis Mohideen, Chief Medical Officer at DBV Technologies, stated, "The compelling results from 36 months of Viaskin Peanut treatment demonstrate a continuation of the very positive efficacy and safety trends that have been previously observed in this study."
Average Daily Wear Time Impacts Efficacy
New data from the Phase 3 EPITOPE study supports the labeling approach proposed to the FDA in June 2024, emphasizing the importance of average daily wear time (ADWT). The analysis revealed that subjects with low day-to-day variability in daily wear time had higher ADWT, which correlated with a more robust efficacy response at 12 months.
- Participants with ADWT ≥20 hours during the first 90 days showed greater month 12 efficacy, according to EPITOPE responder criteria (75.7% vs 47.3%).
- Rates of key safety outcomes of interest were numerically lower in participants with ADWT ≥20 vs <20 hours, based on treatment-related epinephrine use (0.6% vs 2.6%), anaphylaxis (0.6% vs 3.9%), and permanent discontinuations (9.6% vs 19.5%).
Dr. Edwin Kim, Division Chief, Pediatric Allergy & Immunology, University of North Carolina School of Medicine, stated, "Knowing that the ADWT during the first 90 days on treatment is highly predictive of ADWT over a full year and that these data further suggest that ADWT greater than 20 hours show a strong correlation with clinical efficacy response at 12 months will help to guide optimal use of VIASKIN peanut, if approved."
Regulatory Pathway and Future 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.
