21 Aug Viaskin® Peanut: BLA License for Treatment of Peanut-Allergic Children Submitted to FDA

MedicalResearch.com Interview with:

Dr. Todd Green

Todd Green MD
Vice President of Medical Affairs North America
DBV Technologies

Dr. Green discusses the recent announcement that DBV Technologies is submitting a BLA for Viaskin Peanut to the FDA.

MedicalResearch.com: What is the background for this announcement? How common is peanut allergy in children? 

DBV Technologies is a global clinical-stage biopharmaceutical company whose mission is to improve the lives of patients with food allergies and other immunological diseases through our investigational epicutaneous immunotherapy technology platform. For more than 15 years, we’ve been striving to deliver transformative treatments for patients suffering with the burden and life-threatening risk of food allergies.

On August 7, 2019 DBV announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. This submission addressed 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.

Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal allergic reactions, including anaphylaxis. In the United States, nearly one million children suffer from a peanut allergy.^[1] Fear of life-threatening reactions triggered by accidental peanut exposure during everyday activities may lead to significantly increased anxiety and decreased quality of life for patients and their families.^[2,3,4]

Currently, avoidance and readiness to manage accidental exposure reactions remain the standard of care.

At DBV, we are committed to finding treatments that will help address the urgent unmet medical need of those suffering from food allergies, including peanut allergy, and our mission is to improve the lives of those patients and their families.

MedicalResearch.com: For whom would Viaskin Peanut be prescribed? How is it administered?

Neither the technology nor any product have been approved for use or marketing by any health authority in any country, including the United States.

We submitted the BLA to the FDA for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years.

Viaskin is DBV’s proprietary investigational technology platform, based on epicutaneous immunotherapy (EPIT), an investigational method of delivering biologically active compounds to the immune system through the skin.

The potential innovative patch technology could present a self-administered, non-invasive treatment options to patients and families.

MedicalResearch.com: What should readers take away from your report? 

We remain confident in the investigational clinical profile of Viaskin Peanut as observed to date in multiple clinical trials evaluating the prevention of allergic reactions in patients with peanut allergies from accidental peanut exposure. We look forward to continuing to work with FDA through its review process to bring this therapy to market.

Any disclosures?

Neither this technology nor any product have been approved for use or marketing by any health authority in any country, including the United States.

Investigational Epicutaneous immunotherapy is being explored for use to address a broader range of significant unmet medical needs, including vaccines, inflammatory conditions, and autoimmune diseases.

[1] Gupta RS, et al. Pediatrics. 2018;142(6):e20181235.

[2] Greenhawt M, et al. Ann Allergy Asthma Immunol. 2018; 121: 575-579.

[3] Stallings VA, Oria MP. National Academies Press (US). 2017.

[4] Birdi G, et al. J Allergy (Cairo). 2016; 2016:1497375.

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Last Updated on August 21, 2019 by Marie Benz MD FAAD