The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for Viaskin™ Peanut (DBV712; DBV Technologies) in the treatment of peanut allergy in children ages 4 to 11 years.
Viaskin Peanut, an epicutaneous immunotherapy (EPIT), delivers small amounts of peanut protein through a wearable patch to induce desensitization. The Company had initially submitted a BLA in October 2018 but withdrew the application in order to address data needed on manufacturing procedures and quality controls. An updated BLA, which included data from two phase 3 trials (PEPITES and REALISE), four phase 2 trials, and two phase 1 trials, was resubmitted in August 2019.
In the CRL, the FDA noted that it could not approve the BLA due to concerns related to “the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.” Moreover, the Agency indicated that supplementary clinical data would be needed to support the modified patch, as well as additional Chemistry, Manufacturing and Controls data. There have been no reported safety concerns related to Viaskin Peanut.
“We are very disappointed in the FDA’s response, but continue to believe in the potential of Viaskin Peanut,” said Daniel Tassé, Chief Executive Officer of DBV Technologies. “We plan to fully collaborate with the FDA with regards to the outstanding issues and believe that the EPIT patch technology platform lends itself well to potential modifications to enhance patch functionality.”
The Company recently announced long term data from the open-label extension portion of the PEPITES trial. Results showed treatment with Viaskin Peanut was associated with continued response over the 3-year treatment period, with 75.9% (107/141) of patients seeing an improvement in eliciting dose from baseline. Additionally, the mean cumulative reactive dose was found to be 1768.8mg at 36 months, compared with 223.8mg at baseline.
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1. DBV Technologies receives Complete Response Letter from FDA for Viaskin Peanut BLA in children ages 4-11 years. https://www.globenewswire.com/news-release/2020/08/04/2072125/0/en/DBV-Technologies-Receives-Complete-Response-Letter-from-FDA-for-Viaskin-Peanut-BLA-in-Children-Ages-4-11-Years.html. Accessed August 4, 2020.
2. DBV Technologies announces publication of PEOPLE phase III open-label extension study evaluating Viaskin Peanut in The Journal of Allergy and Clinical Immunology. https://www.dbv-technologies.com/wp-content/uploads/2020/07/dbv_jaci-people-publication_press-release_070620.pdf. Accessed August 5, 2020.