DBV Technologies (GREY:DBVTF), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that during its ongoing review of the Biologics License Application (BLA) for investigational Viaskin™ Peanut, it has identified questions regarding efficacy, including the impact of patch-site adhesion. Therefore, the Allergenic Products Advisory Committee (APAC) meeting to discuss the BLA will no longer take place as previously scheduled on May 15, 2020.
The Company is in communication with the FDA regarding the potential submission of additional information on patch-site adhesion from its clinical program as well as long-term efficacy results from the three-year open-label extension study, PEOPLE, to answer FDA's questions, as part of the ongoing BLA review.
At this time, DBV Technologies has received no additional information regarding the timeline of the BLA review, and to the Company's knowledge, the target action date of August 5, 2020 remains unchanged. However, the submission of additional information to the FDA may constitute a major amendment to the BLA and could extend the target action date.
"We appreciate the ongoing dialogue with the FDA and look forward to further discussions in the coming weeks," said Daniel Tassé, Chief Executive Officer of DBV Technologies. "We believe in the clinical benefit observed in Viaskin Peanut clinical trials to date and will continue to work closely with the FDA to potentially bring Viaskin Peanut to children as quickly as possible."
Conference Call Information
The Company will host a conference call and webcast to discuss this update on Monday, March 16, 2020 at 5:00 PM ET (10:00 PM CET). To participate in this conference call, please dial (800) 758-0741 (domestic) or (786) 815-8401 (international). The passcode for the call is 4138917#. The conference call will also be webcast live on DBV's website, www.dbv-technologies.com, under the Investor Relations & Media section and will be archived there for 30 days.