DBV Technologies has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Viaskin Peanut for the treatment of peanut-allergic children aged 4 to 11 years.
The Company had initially submitted a BLA for Viaskin Peanut in October 2018 but withdrew the application in order to address data needed on manufacturing procedures and quality controls.
Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization. The BLA includes data from two phase 3 trials, PEPITES and REALISE, as well as long-term data from an open-label Phase 2 program.
Results of the PEPITES trial showed that a statistically significantly greater proportion of patients treated with Viaskin Peanut had an increase in the amount of peanut protein required to elicit an allergic reaction during the food challenge compared with placebo. Data from the REALISE study further demonstrated a favorable safety and tolerability profile.
The Company is currently investigating the use of Viaskin Peanut in patients aged 1 to 3 years in the phase 3 EPITOPE trial.
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