Complete Response from FDA for Viaskin Peanut patch to treat peanut allergies in children ages 4 to 11 years. DBV Technologies

DBV Technologies announced that the FDA has issued a Complete Response Letter regarding the Company’s Biologics License Application (BLA) for investigational Viaskin Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years. The Complete Response Letter indicates that the FDA cannot approve the application in its present form. The FDA has identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study. The FDA has also indicated that supplementary clinical data would need to be generated to support the modified patch. In addition, the FDA requested additional Chemistry, Manufacturing and Controls data. The Agency did not raise any safety concerns related to Viaskin Peanut. DBV intends to request a meeting with FDA to discuss the FDA’s comments as well as requirements for additional clinical data that may be needed to support BLA resubmission. The Company anticipates providing an update following this meeting, including updated cash runway resulting from the recent restructuring announced on June 26, 2020.