DBV Technologies (NASDAQ:DBVT) slumps 30% premarket in reaction to its announcement that it received a Complete Response Letter (CRL) from the FDA regarding its BLA for investigational Viaskin Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
The CRL cites that the FDA cannot approve the application in its present form. The Agency has identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications, and subsequently a new human factor study.
The Company was also notified that supplementary clinical data would be needed to support the modified patch and a request for additional Chemistry, Manufacturing and Controls data was made. The Agency did not raise any safety concerns related to Viaskin Peanut.
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