Posted by Michael Wonder on 20 Dec 2018
DBV Technologies provides update on Viaskin Peanut for children four to 11 years of age
19 December 2018 - Application withdrawn following discussions with FDA regarding insufficient data on manufacturing procedures and quality controls.
DBV Technologies today announced that after discussions with the U.S. FDA, its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn. DBV is currently working closely with the agency to resubmit the application for Viaskin Peanut as quickly as possible.
This action was based on verbal and written correspondence with the FDA on 18 December 2018. Following feedback from the agency, DBV Technologies concluded that the current BLA, which was submitted on October 18th, 2018, lacks sufficient detail regarding data on manufacturing procedures and quality controls. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut, and the Company believes that the additional information needed to support this filing is available without further clinical studies.
