FDA filing for Viaskin Peanut allergy treatment voluntarily withdrawn.- DBV Technologies.

DBV Technologies has voluntarily withdrawn its Biologics License Application for Viaskin Peanut, its peanut allergy treatment which had been filed with FDA on 22 October 2018. The company states that it will provide more details in the first quarter of 2019.

The FDA has said that its application lacks sufficient detail regarding data on manufacturing procedures and quality controls. However there were no concerns over safety and efficacy, and additional clinical trials should not be required.

Comment: Viaskin is an electrostatic patch, which offers a convenient, self-administered, non-invasive immunotherapy to patients. Once applied on intact skin, Viaskin forms a condensation chamber, which hydrates the skin and solubilizes the antigen allowing it to penetrate the epidermis, where it is captured by Langerhans cells. Based on numerous scientific publications and research, DBV believes, this unique mechanism of action is safe and that it generates a strong and highly tolerogenic immune response. This epicutaneous immunotherapy method allows DBV to address severe food allergies, as well as unmet medical needs in other immunotherapy indications.