DBV Technologies voluntarily withdraws BLA for Viaskin Peanut
DBV Technologies' Biologics License Application for Viaskin Peanut in children four to 11 years of age has been voluntarily withdrawn after discussions with the FDA. DBV is currently working to resubmit the application for Viaskin Peanut as quickly as possible. Following feedback from the agency, DBV Technologies concluded that the current BLA 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. DBV anticipates that all ongoing clinical trials with Viaskin Peanut will continue as planned.