MedicalResearch.com Interview with:
Todd Green MD
Vice President, Medical Affairs North America
Associate Professor of Pediatrics
University of Pittsburgh School of Medicine
MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut?
Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option.
Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure.
In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019.
DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively.
MedicalResearch.com: To whom should Viaskin Peanut be prescribed? How is Viaskin Peanut unique?
Response: As mentioned previously, Viaskin Peanut is currently being evaluated for the treatment of peanut-allergic children ages 4 to 11 years of age.
It is the first and only epicutaneous immunotherapy (EPIT®), a method of delivering biologically active compounds to the immune system through the skin. The innovative patch technology presents no restrictions on patients’ and families’ daily lives with a simple, once daily, non-invasive treatment that patients and caregivers can start and stay with, which was reflected by a nearly 99% (98.5%) adherence rate in the Phase III trial.
MedicalResearch.com: What should readers take away from your announcement?
Response: The detailed feedback the FDA provided in December 2018 allowed DBV to make meaningful headway in addressing all of the information requests needed for a successful BLA resubmission. DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families.
MedicalResearch.com: What future research is planned?
Response: We are studying the use of EPIT with the Viaskin platform across allergies to multiple foods.
There are ongoing Viaskin Peanut trials including the long-term extensions of both the Phase 3 PEPITES and REALISE clinical trials, as well as EPITOPE, our pivotal Phase 3 study of Viaskin Peanut in toddlers 1-3 years of age.
In addition, the Viaskin platform is also being studied in the treatment of cow’s milk and hen’s egg allergy. Viaskin Milk was granted U.S. FDA Fast Track Designation in Sept 2016 and we have recently completed a Phase I/II trial to study the safety and efficacy of Viaskin Milk in pediatric and adolescent patients. Preclinical development for Viaskin Egg is ongoing.
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