Dbv confirms alignment with u.s. fda on accelerated approval pathway for the viaskin® peanut patch in toddlers 1 – 3 years-old

ChÂtillon, france, december 11th, 2024 dbv confirms alignment with u.s. fda on accelerated approval pathway for the viaskin® peanut patch in toddlers 1 – 3 years-old dbv and fda aligned on key study design elements for the comfort toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis comfort toddlers study on-track to initiate in 2q 2025 viaskin peanut patch bla submission for the toddlers indication anticipated for 2h 2026 fda confirmed criteria for post-marketing confirmatory study in toddlers 1 – 3 years-old company to host investor webcast today at 5:00pm et dbv technologies (euronext: dbv – isin: fr0010417345 – nasdaq stock market: dbvt), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral communication with the u.s. food and drug administration (fda) that provides a clear and well-defined regulatory pathway for the viaskin peanut patch program in toddlers 1 – 3-years-old. the fda has formalized guidance on an accelerated approval for the viaskin peanut patch in toddlers 1 – 3-years-old.
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