The manufacturer of the Viaskin Peanut patch has announced plans to resubmit its biologics license application (BLA) for the therapy to the FDA in the third quarter of 2019.
In December, DBV Technologies withdrew the BLA after the FDA told the French pharmaceutical company that the application to lacked “sufficient detail regarding data on manufacturing procedures and quality controls.”
The company says it has made “meaningful headway” since then on the information required.
“We are working diligently on our Viaskin Peanut BLA, bringing us one step closer to potentially providing an FDA-approved treatment for peanut-allergic children and their families,” Daniel Tassé, CEO of DBV Technologies, said in a press release on Feb. 13.
If approved, the patch, which is designed to desensitize peanut-allergic children aged 4 to 11, would be produced through a manufacturer in the south of France.
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