Posted by Michael Wonder on 23 Oct 2018
DBV Technologies announces submission of biologics license application for Viaskin Peanut to the U.S. FDA
22 October 2018 - DBV Technologies today announced the submission of a biologics license application to the U.S. FDA for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age.
Viaskin Peanut is the Company’s lead product candidate, which is based on epicutaneous immunotherapy, a proprietary technology platform that delivers biologically active compounds to the immune system through the skin.
Viaskin Peanut previously received breakthrough and fast track designation from the FDA in 2015 and 2012, respectively. The application for Viaskin Peanut is supported by a global development program comprised of seven clinical trials. Data from Phase III studies, PEPITES and REALISE, which studied patients four to 11 years of age for 12 months, as well as supportive long-term data from the Company’s open-label Phase II program, were included in this submission.
