other material
confidence high
sentiment positive
materiality 0.70
DBV Technologies announces NEJM publication of Phase 3 EPITOPE trial for Viaskin Peanut in toddlers
DBV Technologies S.A.
- NEJM published Phase 3 EPITOPE data showing Viaskin Peanut statistically superior to placebo in desensitizing toddlers (1-3 years) to peanut.
- Treatment responder rates: 67.0% for Viaskin Peanut vs 33.5% for placebo after 12 months.
- No FDA-approved treatment options exist for peanut-allergic children under 4 years; DBV is advancing regulatory efforts for this age group.
- Viaskin Peanut was well-tolerated with low rates of treatment-related anaphylaxis and epinephrine use; local application site reactions decreased over time.
- Editorial in NEJM called the data 'very good news' for toddlers with peanut allergy.