MedPath

DBV Technologies

🇫🇷France
Ownership
-
Employees
104
Market Cap
-
Website
Introduction

DBV Technologies SA is a clinical-stage biopharmaceutical company, which engages in the research and development of epicutaneous immunotherapy products. The firm focuses on the development of Viaskin, an electrostatic patch, which may offer a convenient, self-administered, and non-invasive immunotherapy to patients. It also designs a robust clinical development program that includes ongoing clinical trials of Viaskin peanut, and Viaskin milk, as well as pre-clinical development of Viaskin egg. The company was founded by Pierre-Henri Benhamou, Stéphane Benhamou, Bertrand Dupont, Christophe Dupont, and Pierre-Yves Vannerom on March 29, 2002 and is headquartered in Montrouge, France.

Viaskin Peanut Patch Shows Promise in Toddlers with Peanut Allergy, Gains FDA Accelerated Approval Pathway

• DBV Technologies' Viaskin Peanut patch demonstrates sustained benefits over 36 months in toddlers aged 1-3, improving treatment efficacy and safety. • The FDA has granted an Accelerated Approval pathway for Viaskin Peanut, acknowledging its potential as a significant advancement over existing therapies for peanut allergy. • Data from the EPITOPE Phase 3 trial supports the proposed labeling strategy, highlighting the importance of consistent patch wear time for optimal clinical response. • A confirmatory study with the commercial version of Viaskin Peanut will be conducted to validate its safety and efficacy, with BLA submission expected in 2H 2026.

DBV Technologies Concludes VITESSE Trial Screening for Viaskin Peanut Patch

• DBV Technologies completed screening for its VITESSE Phase 3 trial, surpassing recruitment goals for peanut-allergic children aged 4-7. • The VITESSE trial, evaluating the Viaskin Peanut Patch, is the largest immunotherapy study for this patient group, spanning 86 global sites. • Topline data from the VITESSE trial, assessing the safety and efficacy of Viaskin Peanut Patch, is anticipated in Q4 2025. • DBV Technologies is focusing on advancing the Viaskin Peanut Patch program to support a Biologic License Application submission.
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