DBV Technologies submits BLA to FDA for VIASKIN Peanut Patch in children aged 4-7
DBV Technologies said it has submitted a Biologics License Application to the U.S. Food and Drug Administration for its VIASKIN Peanut Patch in children with peanut allergy aged 4 through 7 years, and has requested Priority Review. The application is supported by results from the Phase 3 VITESSE trial, which enrolled 654 children, and the FDA previously granted the patch Breakthrough Therapy Designation. The filing reports a regulatory milestone, not revenue or approval, and the company states the product has not been authorized for sale in any country.
Key points
- BLA submitted to the FDA for VIASKIN Peanut Patch in children aged 4 through 7 years, announced September 29, 2026
- DBV has requested Priority Review; the FDA previously granted Breakthrough Therapy Designation
- VITESSE Phase 3 trial enrolled 654 children, randomized 2:1 to active patch or placebo
- The company states the product has not been authorized for sale in any country
The filing
Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 29, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.