DBV remains on track to submit its BLA for Viaskin Peanut for the treatment of peanut allergy in the second half of 2018.</p>

DBV announced that the FDA has agreed that the available efficacy and safety data for Viaskin Peanut supports the submission of a Biologics License Application (BLA) for the treatment of peanut allergy in children four to 11 years of age.

The FDA provided written responses to the clinical pre-BLA meeting package submitted by the Company, which reflect agreement on the content of the clinical module of the BLA for Viaskin Peanut. DBV remains on track to submit its BLA in the second half of 2018.

Peanut allergy can be triggered by even traces of the allergen, and keeping safe involves a strict regimen of avoiding certain foods and carrying auto-injectors such as EpiPens in case of accidental exposure. Peanut allergy prevalence in children jumped 21% between 2010 and 2016, with as many as 2.5% of children in the U.S. now allergic to peanuts.