Date: 2015-06-04
Type of information: Clinical trial authorization
phase: 3 - pediatric
Announcement: clinical trial authorization
Company: DBV Technologies (France)
Product: Viaskin® Peanut
Action
mechanism: immunotherapy product. Viaskin® is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream. Viaskin® Peanut is currently being investigated in clinical trials for treatment of peanut allergy.
Disease: peanut allergy
Therapeutic area: Allergic diseases
Country:
Trial details:
Latest
news: * On June 4, 2015, DBV Technologies has announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) adopted a positive opinion agreeing the company’s PIP for Viaskin® Peanut. As part of the regulatory process for the registration of new medicines in Europe, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in pediatric population. An accepted PIP is a prerequisite for the filing for marketing authorization for any new medicinal product in Europe.
DBV Technologies’ PIP provides a comprehensive clinical development plan for Viaskin® Peanut in pediatric population from 1 to 17 years of age, in particular the features of the phase III program in children. The positive opinion on the Company’s PIP already takes into account the statistically significant Phase IIb trial results with Viaskin Peanut. The Viaskin® Peanut Efficacy and Safety trial, or VIPES, is a Phase IIb study demonstrating that Viaskin Peanut 250?g improved the peanut allergy disease in children. Available safety data from past and ongoing studies with Viaskin Peanut demonstrate a robust safety profile in children, adolescents and adults.
