DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
PRESS RELEASE GlobeNewswire
Aug. 7, 2019, 04:05 PM
Montrouge, France, August 7, 2019
DBV Technologies Submits Biologics License Application to U.S. Food and Drug Administration for Viaskin Peanut for the Treatment of Peanut Allergy
DBV Technologies (Euronext: DBV - ISIN: FR0010417345 - Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (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 (EPIT®). Viaskin is the Company’s proprietary, investigational platform that is designed to leverage the skin to activate the immune system and induce desensitization 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 BLA submission for Viaskin Peanut. The FDA did not cite concerns related to the clinical module of the BLA for Viaskin Peanut in December 2018.
“This is an important milestone for DBV, as we are one step closer towards potentially bringing Viaskin Peanut to patients.I want to thank the team for their dedication in working to address the FDA’s findings over the past few months. Everyone at DBV is highly committed to potentially addressing the significant unmet medical need facing peanut-allergic patients,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “We would also like to thank our investigators, clinical trial sites, as well as the children living with peanut allergy and their families for all of their help in the development of Viaskin Peanut. We look forward to working with the FDA throughout its review process.”
Viaskin Peanut received Breakthrough and Fast Track Designation from the FDA in 2015 and 2012, respectively. The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including, two Phase I studies, four Phase II studies and two Phase III studies. The two double-blind placebo-controlled Phase III trials, PEPITES and REALISE, studied patients aged 4 to 11 years for 12 months and 6 months, respectively, and were included in the submission. Additionally, supportive long-term data from the Company’s open-label Phase II program were also included in the submission.
