DBV Technologies Outlines Q4 2026 BLA Submission and H1 2027 US Launch Plans
DBV Technologies plans to submit its BLA for Viaskin Peanut in Q4 2026 after presenting VITESSE Phase 3 topline data demonstrating a 67% sustained desensitization rate at 12 months. Management detailed a mid-2027 US commercial launch targeting an estimated 200,000 pediatric peanut-allergic patients.
1. BLA Submission Timeline
DBV Technologies confirmed it will submit the Biologics License Application for Viaskin Peanut in Q4 2026, with FDA acceptance expected by mid-2027. This timeline follows completion of rolling modules and final manufacturing validation.
2. VITESSE Phase 3 Results
The pivotal VITESSE trial showed a 67% sustained desensitization rate at 12 months versus placebo, meeting its co-primary endpoints on both safety and efficacy. Patient adherence exceeded 90% over the one-year study period.
3. Commercial Launch Strategy
The company outlined plans for a mid-2027 US launch, targeting roughly 200,000 pediatric peanut-allergic children. Pricing, payer contracting and multi-channel provider training programs are being finalized ahead of rollout.