Posted by Michael Wonder on 04 Aug 2020
DBV Technologies receives complete response letter from FDA for Viaskin Peanut BLA in children ages 4-11 years
4 August 2020 - DBV Technologies today announced that the U.S. FDA has issued a complete response letter regarding the Company’s biologics license application 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.
