DBV Technologies (DBVT) announced that the Food and Drug Administration has issued a Complete Response Letter regarding the company's Biologics License Application for Viaskin Peanut, a 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 company said in a statement. 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, DBV added. The company intends to request a meeting with FDA to discuss the FDA's comments as well as requirements for additional clinical data that may be needed to support BLA resubmission.

"We are very disappointed in the FDA's response, but continue to believe in the potential of Viaskin Peanut. Peanut allergy is one of the most common food allergies, and accidental exposure can result in life-threatening reactions," Daniel Tasse, CEO of DBV Technologies, stated.

"We plan to fully collaborate with the FDA with regards to the outstanding issues and believe that the EPIT patch technology platform lends itself well to potential modifications to enhance patch functionality. We remain dedicated in our mission to develop innovative treatments for patients with food allergies."