DBV Tech Files BLA for Peanut Allergy Patch

DBV Technologies has submitted a BLA for the VIASKIN Peanut Patch in children with a peanut allergy aged 4 through 7 years. The company says it requested a priority review for the submission.

The patch uses epicutaneous immunotherapy, which the company describes as an innovative, non-oral, non-injection approach to food allergy treatment that delivers small amounts of an allergen protein through the skin. “By using the immune properties of the skin, the VIASKIN Peanut Patch is designed to progressively desensitize children to peanut allergy,” the company says.

The submission is supported by the positive results from the VITESSE Phase 3 clinical trial of the therapy in 654 children ages 4 through 7 years with peanut allergy, according to the company, calling it the “largest immunotherapy clinical trial to date for this population.” The primary endpoint is the difference between the percentage of treatment responders in the active versus placebo group after 12 months of treatment.