The manufacturer of the Viaskin Peanut patch has withdrawn its biologics license application (or BLA) with the FDA, but has plans to resubmit it “as quickly as possible” in 2019.
In a statement, DBV Technologies said the move comes after the FDA told the pharmaceutical company that its application to approve the patch for peanut-allergic children “lacks sufficient detail regarding data on manufacturing procedures and quality controls.”
The company said it “believes the additional information needed to support this filing is available without further clinical studies.”
“During this review, it is important to note that the FDA did not cite concerns related to the safety or efficacy of Viaskin Peanut in the BLA,” Joseph Becker, DBV Technologies’ vice president of global corporate communications, told Allergic Living.
“Their feedback was regarding insufficient data on manufacturing procedures and quality controls. No other feedback was provided on the BLA,” he said.
If approved, the Viaskin patch, which is designed to desensitize peanut-allergic children aged 4 to 11, would be produced through a manufacturer in the south of France.
Becker said DBV Technologies is evaluating answers to the FDA’s request for more information. “While we can’t yet speak to our precise timeline, our focus is on addressing the agency’s concerns as quickly as possible and resubmitting an updated BLA.”
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