DBV Technologies Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for Viaskin Peanut Patch in Toddlers 1-3 Years-Old

On December 11, 2024, DBV Technologies S.A. announced its successful alignment with the U.S. Food and Drug Administration (FDA) regarding the regulatory pathway for the Viaskin Peanut patch program in toddlers aged 1-3 years. The company issued a press release titled “DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin ® Peanut Patch in Toddlers 1-3 Years-Old,” signaling a significant step forward in its regulatory processes.

The FDA and DBV have agreed on crucial study design elements for the upcoming COMFORT Toddlers study, including aspects such as study size, wear time collection methodology, and analysis. This alignment has set the stage for the initiation of the COMFORT Toddlers study, which is expected to commence in the second quarter of 2025. The Viaskin Peanut patch Biologics License Application (BLA) submission for the toddlers’ indication is anticipated to take place in the second half of 2026.

Furthermore, the FDA has outlined criteria for a post-marketing confirmatory study in toddlers aged 1-3 years. The confirmatory study will evaluate the effectiveness of the commercial Viaskin Peanut patch and is planned to start simultaneously with the BLA submission. Notably, the FDA and DBV have reached a consensus on the details of this study, which will include a double-blind, placebo-controlled food challenge among other assessments.

DBV Technologies CEO, Daniel Tassé, expressed satisfaction with the FDA’s guidance, viewing it as a positive step towards achieving Accelerated Approval for the Viaskin Peanut patch in toddlers aged 1-3 years. This development follows previous announcements by DBV regarding the Viaskin Peanut programs across different age groups in both the U.S. and Europe.

In a bid to further enhance its regulatory pathway, DBV has made modifications to the Viaskin Peanut patch and manufacturing processes to streamline application for caregivers and boost patch production. The company aims to leverage the positive outcomes of its discussions with the FDA to advance its clinical trials and eventual commercialization plans.

Investors and stakeholders interested in learning more about these regulatory updates can access the investor conference call and webcast hosted by DBV management on December 11, 2024. The call will provide further insights into DBV’s strategies and progress regarding the Viaskin Peanut patch program and related studies.

Overall, DBV Technologies remains committed to revolutionizing the treatment of food allergies and addressing significant unmet medical needs through its innovative Viaskin patch technology, with a specific focus on enhancing the lives of individuals with food allergies.

Contact:
Katie Matthews, Investor Contact, DBV Technologies
[email protected]

Angela Marcucci, Media Contact, DBV Technologies
[email protected]

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read DBV Technologies’s 8K filing here.

DBV Technologies Company Profile

DBV Technologies SA, a clinical-stage biopharmaceutical company, engages in the research and development of epicutaneous immunotherapy products. Its product pipeline comprising Viaskin Peanut, an immunotherapy product, which has completed Phase 3 clinical trial for the treatment of peanut allergies; and Viaskin Milk which is in Phase 1/2 clinical trial for the treatment of immunoglobulin E (IgE) mediated or cow’s milk protein allergy and eosinophilic esophagitis.