EMA Pediatric Committee Adopts Positive Opinion on Peanut Allergy Treatment for Children
The pediatric investigation plan provides a clinical development plan for Viaskin Peanut in pediatric population. DBV Technologies will now be able to submit a marketing authorization application in Europe following completion of the Viaskin Peanut Phase III trials.
Biopharmaceutical company DBV Technologies announced that the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has adopted a positive opinion on the company's pediatric investigation plan for Viaskin Peanut for the treatment of peanut allergy in children.
The European regulatory framework requires pharmaceutical companies to provide a pediatric investigation plan outlining their strategy for assessing new medicinal products in children. Acceptance of the pediatric investigation plan is a prerequisite for the filing a marketing authorization application for a new medicinal product in Europe.
The pediatric investigation plan provides a clinical development plan for Viaskin Peanut in pediatric population from 1 to 17 years of age, in particular the details of the Phase III trials. DBV Technologies will now be able to submit a marketing authorization application in Europe following completion of the Viaskin Peanut Phase III trials.
Viaskin Peanut is an electrostatic patch, based on epicutaneous immunotherapy (EPIT), which delivers an allergen onto the skin. Antigen-presenting cells are targeted to activate the immune system without allowing passage of the antigen into the bloodstream. The patch has shown good safety profile in past and ongoing studies.
Source: DBV Technologies
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