7 August 2019 - DBV Technologies today announced the submission of its biologics license application to the U.S. FDA for Viaskin Peanut for the treatment of peanut-allergic children ages 4 to 11 years. 

Viaskin Peanut is the Company’s lead product candidate based on epicutaneous immunotherapy. Viaskin is the Company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitisation to allergens.

This submission addresses the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior submission for Viaskin Peanut. The FDA did not cite concerns related to the clinical module of the application for Viaskin Peanut in December 2018.

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