Long journey for DBV peanut patch ends in rejection by FDA
DBV Technologies’ long and winding saga with the FDA has ended — for now, at least — with a CRL for their peanut allergy skin patch.
The rejection comes 21 months after the company first filed for approval. At the time, the French biotech was in a two-way race with California’s Aimmune to produce the first FDA-approved treatment for peanut allergy. But since then Aimmune cleared that hurdle, while DBV, after a withdrawal and resubmission, indicated that communication between them and regulators had broken down. In June, the company began cutting programs and employees.
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