DBV Technologies Submits MAA to EMA for Viaskin™ Peanut, a Non-Invasive Epicutaneous Patch for Peanut Allergy in Children Aged 4–11

November 03, 2020 /BioValleyBIOON/ -- French biotechnology company DBV Technologies recently announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for Viaskin Peanut (DBV712), a patch for peanut allergy, and has initiated a formal review. The product is aA non-invasive, once-daily skin patch that gradually trains the immune system to develop tolerance to peanuts, indicated for the treatment of peanut allergy in children aged 4–11 years.

Following the announcement, DBV’s stock price surged by 85%. Regarding U.S. regulatory matters, DBV received a Complete Response Letter (CRL) from the FDA in August 2020 concerning the Biologics License Application (BLA) for Viaskin Peanut. The company is currently engaging with the FDA to discuss future regulatory pathways. In 2015,FDAViaskin Peanut Has Been Granted Breakthrough Therapy Designation (BTD) for the Treatment of Peanut Allergy.

The Viaskin Peanut patch, developed using DBV Technologies’ Viaskin platform, gradually trains the human immune system to develop tolerance to peanuts.Viaskin is an electrostatic patch that delivers bioactive substances (including allergens) through intact skin without disrupting the skin barrier. Its theoretical foundation is epicutaneous immunotherapy (EPIT), which directly delivers allergens to the superficial layers of the skin, activating the body’s immune system by specifically targeting antigen-presenting cells (APCs), while preventing allergens from entering the bloodstream.In addition to Viaskin Peanut, DBV Technologies is also developing Viaskin patches for the treatment of dust mite allergy and cow’s milk allergy.

Peanut allergy is one of the most common food allergies worldwide, with more than 1.6 million children and adolescents in the United States alone affected by it. The standard of care for children and adolescents with peanut allergy has always been a strict peanut elimination diet, along with timely administration of rescue medications in case of accidental ingestion leading to allergic reactions. Despite maintaining high vigilance, accidental ingestion may still occur, resulting in unpredictable allergic reactions and a lifelong risk of severe anaphylaxis.

This February, Aimmune Therapeutics'Palforzia Oral Immunotherapy for Peanut Allergy(Peanut Allergen Powder-dnfp, AR101) received U.S.FDA, becomingThe first therapy approved globally for the treatment of peanut allergy, and also the first therapy approved globally for the treatment of any food allergy.

Palforzia is the first product developed using Aimmune’s proprietary CodiT™ (Concurrent Oral Desensitization Immunotherapy) platform, which is designed to desensitize patients by administering clearly defined, precise quantities of key allergens, thereby providing a meaningful level of protection against immune responses triggered by accidental ingestion of food allergens.

Palforzia consists of key allergens extracted from peanuts and is a powder with a fixed composition, packaged in pull-apart, color-coded capsules (for dose escalation and up-dosing) and sachets (300 mg/sachet, for maintenance therapy). For administration, the powder is removed from the capsule or sachet, mixed with a small amount of semi-solid food (such as applesauce, yogurt, or pudding), and then consumed.

Peanut allergy represents a $3 billion market. As the first drug approved for treating peanut allergy, Palforzia is highly anticipated by the industry for its commercial prospects. Pharmaceutical market research firm EvaluatePharma previously predicted that Palforzia’s sales would reach $1.75 billion in 2024. (Bioon.com)

Original Source: DBV Technologies Announces Filing and Validation of Marketing Authorizationapplication for Viaskin™ Peanut by European Medicines Agency