Treatment for Peanut Allergies: Update on Viaskin Peanut
An estimated 8% of children in the United States (U.S.) have a food allergy. The prevalence of food allergies in children under 18 in the U.S. has increased by an estimated 50% from 1997 to 2011.
Peanut allergy is one of the most common food allergies that can cause potentially severe allergic reactions. Approximately 1.5 million children are affected by a peanut allergy. While it is possible to grow out of it, research indicates that only about 20% do.
There is a new patch treatment for children in development, looking to reduce the risk of a reaction to peanuts' accidental ingestion. Check out below for more information about Viaskin Peanut.
Viaskin Peanut is a patch currently in drug development going through clinical trials to obtain U.S. Food and Drug Administration (FDA) approval to treat peanut allergy in children ages 4 to 11.
Viaskin Peanut delivers allergens (peanuts) to someone's immune system through a skin treatment known as epicutaneous immunotherapy (EPIT). The patch aims to desensitize someone to an allergen (peanuts) by delivering small quantities (250 micrograms of peanut protein) daily in the skin's outer layers. The patch intends to reduce the risk of reactions to accidental peanut ingestion.
The drug development process goes from discovery and development to preclinical research, clinical research, FDA drug review, and finally to FDA post-market drug safety monitoring.
Viaskin Peanut is currently in the clinical research stage, completing Phase 3 clinical trials. REALISE (Real Life Use and Safety of EPIT) is a Phase 3 trial focusing on the adverse reactions seen from Viaskin Peanut use. Below are more details about two of the clinical trials that looked into the efficacy of the patch:
The PEPITES (Peanut EPIT Efficacy and Safety Study) trial looked at the safety and efficacy of Viaskin Peanut in children ages 4 to 11 years old by comparing it to a placebo.
This study looked at if, after 12 months of Viaskin Peanut treatment, the patients could tolerate a higher elicit dose – the highest dose of when symptoms of an immediate allergic reaction developed – of peanuts.
The results showed that patients who used Viaskin Peanut had statistically significant increases in their elicit dose levels than those who used the placebo.
The PEOPLE trial is an extension trial of PEPITES. Patients received Viaskin Peanut for either two years, if they received the active treatment in PEPITES, or three years if they received the placebo in PEPITES.
This trial's focus is to see if the positive improvements seen in PEPITES would continue over a longer period.
The interim results show that overall, an increase in the elicit dose levels is seen in 75.9% of participants originally in the active treatment group of PEPITES. This study is ongoing, so longer-term data will be available to see whether there continues to be an increase in benefit.
Recent News for Viaskin Peanut
Viaskin Peanut had previously obtained Fast Track and Breakthrough Therapy designation from the FDA to treat peanut allergy in children. In August 2020, the FDA turned down Viaskin Peanut for approval in its current form. The FDA indicated a need for the following:
- Patch modifications – specifically looking at the impact of patch-site adhesion on the efficacy
- New human factor study
- Further clinical data to support patch modifications
- Additional Chemistry, Manufacturing, and Controls data
There was no indication from the FDA of any safety concerns related to Viaskin Peanut.
In response to the FDA notice, Daniel Tassé, the Chief Executive Officer of DBV Technologies, stated that "we plan to fully collaborate with the FDA with regards to the outstanding issues and believe that the EPIT patch technology platform lends itself well to potential modifications to enhance patch functionality. We remain dedicated in our mission to develop innovative treatments for patients with food allergies."
Peanut allergy is one of the most common food allergies that can cause severe allergic reactions. Currently in drug development is Viaskin Peanut, a patch that works by a skin treatment (EPIT), which delivers a small amount of allergen to the skin each day. This patch aims to reduce the risk of reactions to the accidental ingestion of an allergen.
Viaskin Peanut is in Phase 3 clinical trials. It indicates some positive results, but recent news from the FDA states that modifications and additional data are needed for future approval.
DBV Technologies website. https://www.dbv-technologies.com/. Accessed September 2, 2020.
Development Pipeline. DBV Technologies website. https://www.dbv-technologies.com/pipeline/viaskin-peanut/. Accessed September 2, 2020.
Step 3: Clinical Research. U.S. Food & Drug Administration website. https://www.fda.gov/patients/drug-development-process/step-3-clinical-research. Updated January 4, 2018. Accessed September 2, 2020.
Safety Study of Viaskin Peanut to Treat Peanut Allergy (REALISE). U.S. National Library of Medicine website. https://clinicaltrials.gov/ct2/show/NCT02916446?term=realise&rank=4. Updated May 7, 2020. Accessed September 2, 2020.
Fleischer DM, Greenhawt M, Sussman G, et al. Effect of Epicutaneous Immunotherapy vs Placebo on Reaction to Peanut Protein Ingestion Among Children With Peanut Allergy: The PEPITES Randomized Clinical Trial. JAMA. 2019;321(10):946-955. doi:10.1001/jama.2019.1113
Fleischer DM, Sussman G, Beyer K, et al. Open-Label Follow-Up of the PEPITES Study (PEOPLE) to Evaluate the Long-Term Efficacy and Safety of Epicutaneous Peanut Immunotherapy in Peanut-Allergic Children. J Allergy Clin Immunol. 2020;145(2 Supplement): AB141. doi:10.1016/j.jaci.2019.12.453
Fleischer DM, Sussman G, Beyer K, et al. Open-Label Follow-Up of the PEPITES Study (PEOPLE) to Evaluate the Long-Term Efficacy and Safety of Epicutaneous Peanut Immunotherapy in Peanut-Allergic Children. Poster presented at: American Academy of Allergy, Asthma and Immunology; March 13-16, 2020 (meeting canceled – presentations available online).
DBV Technologies S.A. DBV Technologies Receives Complete Response Letter From FDA For Viaskin Peanut BLA In Children Ages 4-11 Years.; 2020. https://www.globenewswire.com/news-release/2020/08/04/2072125/0/en/DBV-Technologies-Receives-Complete-Response-Letter-from-FDA-for-Viaskin-Peanut-BLA-in-Children-Ages-4-11-Years.html. Accessed September 2, 2020.