Dbv announces positive regulatory updates for the viaskin® peanut patch in the united states and europe

ChÂtillon, france, october 22, 2024 dbv announces positive regulatory updates for the viaskin® peanut patch in the united states and europe dbv to pursue an accelerated approval pathway for toddlers ages 1 – 3 years-old  bla submission under accelerated approval is subject to completion of a six-month supplemental safety study in toddlers to be initiated in q2 2025 vitesse phase 3 study evaluating the viaskin peanut patch in children ages 4 – 7 years-old exceeded enrollment goals; topline results on track for 4q 2025    european medicines agency (ema) scientific advice confirms registration path for a marketing authorization application (maa) with the modified viaskin peanut patch for a 1 – 7 year-old indication in europe company to host investor conference call at 5:00pm et today dbv technologies (euronext: dbv – isin: fr0010417345 – nasdaq stock market: dbvt), a clinical-stage biopharmaceutical company, today announced positive regulatory updates for the viaskin peanut patch in the united states and europe. dbv has agreed to guidance provided by the u.s. food and drug administration (fda) on a pathway under the accelerated approval program for the viaskin peanut patch in toddlers ages 1 – 3 years-old and has also received scientific advice from the ema on a 1 – 7 year-old indication in europe.
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