DBV submits FDA BLA for VIASKIN Peanut Patch in children ages 4-7
DBVT•DBV Technologies submitted an FDA biologics license application for its VIASKIN Peanut Patch in children ages 4-7, seeking Priority Review; the filing is supported by Phase 3 data from 654 children.
1. FDA application submitted
DBV Technologies submitted a biologics license application to the FDA for its VIASKIN Peanut Patch in children aged 4-7 and is seeking Priority Review. The FDA previously granted the product Breakthrough Therapy designation. The application is supported by Phase 3 VITESSE data from 654 children, described as the largest immunotherapy trial in this population.
