DBV Shares Positive Regulatory Updates for Viaskin® Peanut Patch in US and Europe

DBV Technologies has announced promising regulatory updates regarding their Viaskin Peanut Patch for toddlers and children with peanut allergies, both in the United States and Europe. The company, headquartered in Châtillon, France, is making strides towards meeting the unmet medical needs of young children suffering from peanut allergies, a condition that can be life-threatening and for which few treatments are currently available.

In the United States, DBV Technologies has reached an agreement with the Food and Drug Administration (FDA) to pursue the Accelerated Approval pathway for the Viaskin Peanut patch for toddlers aged 1 to 3 years. This pathway allows for expedited approval of treatments for serious conditions where there is an unmet medical need. The agreement follows guidance provided by the FDA, including criteria that the treatment should provide a significant improvement over existing therapies and demonstrate an effect on a clinical endpoint likely to predict clinical benefit. DBV plans to formalize this guidance through a meeting request submission.

The process involves a supplemental safety study known as COMFORT Toddlers, which is scheduled to commence in the second quarter of 2025. This study will enroll approximately 300 to 350 toddlers, adding to the existing safety data and bringing the total number of subjects to around 600, as per previous FDA guidance. The study aims to generate sufficient data to support a Biologics License Application (BLA) submission, anticipated to be supported by positive efficacy and safety data from DBV's completed EPITOPE Phase 3 study and additional data from the COMFORT Toddlers study.

DBV Technologies is also making significant progress in Europe. They have received scientific advice from the European Medicines Agency (EMA) confirming a registration path for a Marketing Authorization Application (MAA) for the Viaskin Peanut patch in children aged 1 to 7 years. This advice aligns with previous guidance from local country regulatory health authorities and suggests that the results from the EPITOPE study in toddlers and a positive outcome from the ongoing VITESSE Phase 3 study in children aged 4 to 7 years could form the basis for the MAA submission. A new safety study in toddlers aged 1 to 3 years with the modified patch is also planned to meet European regulatory requirements.

The VITESSE study, which has exceeded its enrollment goals with 654 children participating, aims to provide topline results in the fourth quarter of 2025. This study, along with the COMFORT Children safety study expected to begin in the second quarter of 2025, will be critical for the BLA submission for the 4 to 7-year-old age group.

These advancements are seen as significant steps forward in the treatment of peanut allergies in young children. Dr. David Fleischer, a Professor of Pediatrics at Children’s Hospital Colorado, highlighted the potential of the Viaskin Peanut patch to improve the lives of peanut-allergic toddlers and their caregivers, given the limited treatment options currently available.

From a financial perspective, DBV Technologies reported cash and cash equivalents of $46.4 million as of September 30, 2024. The company has experienced a net decrease in cash due to ongoing operating expenses, primarily related to the VITESSE Phase 3 clinical trial and other regulatory and medical activities. Despite this, the company remains committed to advancing its research and development efforts and preparing for the potential launch of the Viaskin Peanut patch, should it receive approval.

DBV Technologies continues to engage with regulatory agencies in the United States and Europe to navigate the approval processes for the Viaskin Peanut patch. The company is optimistic about the potential impact of its treatment on the food allergy community and remains dedicated to addressing the significant unmet medical needs of individuals with peanut allergies.