Nut a Problem

A growing body of literature suggests that consuming peanuts during infancy may significantly reduce the risk of developing an allergy in later life. Scientists have conceived of numerous approaches to desensitize the body to allergens (such as peanuts), but there are currently no FDA-approved options for children under the age of four years. That soon may change with DBV Technologies’ epicutaneous immunotherapy (EPIT) – the aptly named Viaskin Peanut.

Phase III trial results, published in the New England Journal of Medicine, showed that Viaskin Peanut was statistically superior to placebo in desensitizing toddlers under the age of four years to peanuts after 12 months of treatment. According to the article, “The developing immune system may be particularly amenable to desensitization, which provides an important rationale for prioritizing treatments that target younger children.”

The therapy, which is delivered using a patch, harnesses the immune properties of the skin to modify underlying food allergies and has the potential to desensitize the immune system to other allergens. Importantly, the trial’s primary efficacy endpoint test was met – and the results aligned with the safety profile observed in prior clinical trials involving children aged four years and older with peanut allergies. Furthermore, more than one-third of Viaskin Peanut-treated participants reached a cumulative reactive dose that indicated a significant reduction in the risk of anaphylaxis from accidental peanut exposure. Approximately 67 percent of those using the real patch were able to tolerate more peanuts than before.

In a statement, DBV Technologies' CEO, Daniel Tasséhe, said, “Parents and caregivers are eagerly awaiting FDA-approved treatment options for this age group. We are pleased that the NEJM has confirmed what we know to be true: the EPITOPE data represent a next step towards a future with more [approved] treatments for food allergies.”

The publication comes shortly after receiving pre-BLA feedback from the FDA, which outlined the regulatory path for our Viaskin Peanut program in 1–3-year-olds.