DBV Technologies announced Wednesday that after discussions with the US Food and Drug Administration (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its Biologics License Application (BLA) for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn.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 as quickly as possible.
DBV took this action based on verbal and written correspondence with the FDA on December 18th, 2018. Following feedback from the agency, the company concluded that the current BLA, which was submitted in October, lacked 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.
Said Daniel Tassé, Chief Executive Officer of DBV Technologies:
Although the agency did not reference any medical or clinical questions with the submission of Viaskin Peanut, the FDA did communicate that the level of detail with regards to data on manufacturing and quality controls was insufficient in the BLA. We remain confident in the clinical profile of Viaskin Peanut and its potential to offer treatment to peanut-allergic children. Our plan is to address these concerns as quickly as possible and to work closely with the FDA to provide an updated and complete file.