DBV Technologies, a clinical-stage biopharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for its investigational Viaskin Peanut immunotherapy for the treatment of peanut-allergic children ages 4 to 11 years.
Viaskin Peanut is the Company’s lead product candidate designed to potentially reduce the risk of life-threatening allergic reactions due to accidental exposure to peanuts. A non-invasive, once-daily, epicutaneous patch, Viaskin Peanut seeks to deliver microgram quantities of peanut antigen to activate the immune system.
Viaskin Peanut is based on investigational epicutaneous immunotherapy (EPIT®), DBV’s proprietary method of delivering biologically active compounds to the immune system through intact skin.
“The acceptance of the Viaskin Peanut BLA is a meaningful step forward for peanut-allergic patients and their families,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies.
“We commend the tireless efforts of the DBV team, the investigators and the more than 1,000 patients living with peanut allergies who participated in our clinical trials and made this milestone possible. We know children and their families are seeking a safe and effective treatment that may fit into their daily lives. We look forward to continuing to work with the FDA to potentially bring Viaskin Peanut to patients in the second half of 2020.”
The target action date provided by the FDA is August 5, 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.
The BLA for Viaskin Peanut is supported by a global development program comprised of eight clinical trials including two Phase I clinical trials, four Phase II clinical trials, and two Phase III clinical trials (PEPITES and REALISE).
The FDA’s acceptance of the Viaskin Peanut BLA submitted on August 6, 2019 follows the December 2018 withdrawal of the Company’s previously submitted BLA.
Viaskin Peanut has not been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other health authority. The safety and efficacy of Viaskin Peanut have not been evaluated by the FDA or any other health authority.
Source: Company Press Release