DBV Technologies has announced significant regulatory advancements for its Viaskin Peanut patch, a potential treatment for peanut allergies in young children. The U.S. Food and Drug Administration (FDA) has agreed to an Accelerated Approval pathway for toddlers aged 1-3 years, while the European Medicines Agency (EMA) has confirmed a registration path for children aged 1-7 years in Europe. These developments represent a significant step forward in addressing the unmet medical need for safe and effective peanut allergy treatments in young patients.
Accelerated Approval in the US
The FDA's decision to grant an Accelerated Approval pathway is based on the understanding that the Viaskin Peanut patch addresses a serious condition and offers a potentially meaningful advantage over existing therapies. To secure final approval, DBV Technologies must complete a supplemental safety study, COMFORT Toddlers, which is scheduled to begin in the second quarter of 2025 and enroll approximately 300-350 subjects. This study will expand the safety database for the Viaskin Peanut patch in toddlers to approximately 600 subjects, aligning with prior FDA guidance.
Daniel Tasse, Chief Executive Officer of DBV Technologies, stated, "Our agreement with FDA guidance on a path towards Accelerated Approval for the Viaskin Peanut patch in 1 - 3 year-olds represents a significant step forward in getting this novel treatment to patients. I am pleased that the FDA recognizes the urgent unmet medical need that exists for this young patient population."
Progress in Europe
In Europe, the EMA has provided scientific advice confirming that the completed EPITOPE study in 1-3 year-olds, along with positive results from the VITESSE study in 4-7 year-olds, could support a Marketing Authorization Application (MAA) for a 1-7 year-old indication. This pathway is contingent on a new safety study in 1-3 year-olds using the modified Viaskin Peanut patch.
The potential for a single patch to treat peanut allergies in a broader age range (1-7 years) in Europe is a significant advantage. The European Academy of Allergy & Clinical Immunology (EAACI) draft Guidelines on the Management of IgE-mediated Food Allergy suggest epicutaneous immunotherapy to achieve desensitization in children and adolescents with IgE-mediated peanut allergy, further supporting the potential clinical benefit of the Viaskin Peanut Patch.
VITESSE Phase 3 Trial
DBV Technologies has completed patient screening for the Phase 3 VITESSE trial, enrolling 654 children aged 4-7 years. Topline data from this trial are expected in the fourth quarter of 2025. The COMFORT Children safety study, expected to begin in the second quarter of 2025, will enroll approximately 250 subjects, bringing the total number of 4-7 year-olds on active treatment to approximately 600.
Financial Considerations
Despite the positive regulatory updates, DBV Technologies faces financial challenges. As of September 30, 2024, the company's cash and cash equivalents amounted to $46.4 million, a decrease from $66.2 million on June 30, 2024. The company anticipates that its current cash reserves will only fund operations into the first quarter of 2025 and is actively seeking additional capital to support its research and development efforts and potential product launch.
Addressing Patch Adhesion
Discussions between DBV and the FDA have also addressed the patch’s adhesion issues. The company proposed a labeling solution that links adhesion data to the patch’s efficacy and safety, which the FDA appears to have accepted as a viable path forward.
Expert Opinion
Dr. David Fleischer, Professor of Pediatrics at Children's Hospital Colorado, stated, "DBV's Viaskin Peanut patch has the potential to significantly improve the lives of peanut allergic toddlers and their caregivers. With few approved treatment options for this patient population - the age range in which most young people are initially diagnosed with peanut allergy - the Viaskin Peanut patch has the potential to be a game changer in the food allergy community, and I look forward to having the opportunity to incorporate it into my own practice, if approved."
