Posted by Michael Wonder on 05 Oct 2019
DBV Technologies announces FDA acceptance of BLA filing for Viaskin Peanut for the treatment of peanut allergy
4 October 2019 - If approved, Viaskin Peanut would be the first and only epicutaneous immunotherapy indicated for this potentially life-threatening condition in children.
DBV Technologies today announced that the U.S. FDA has accepted for review the biologics license application for its investigational Viaskin peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
The target action date provided by the FDA is 5 August 2020. The FDA has communicated that it is currently planning to hold an advisory committee meeting to discuss the Viaskin Peanut application. Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively.
