Posted by Michael Wonder on 18 Mar 2020
DBV Technologies provides update on Viaskin Peanut BLA for children ages 4-11 years
16 March 2020 - DBV Technologies today announced that the U.S. FDA has informed the Company that during its ongoing review of the biologics license application for investigational Viaskin Peanut, it has identified questions regarding efficacy, including the impact of patch-site adhesion.
Therefore, the Allergenic Products Advisory Committee meeting to discuss the application will no longer take place as previously scheduled on 15 May 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 review.
