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Medical Devices / Submissions and Approvals

DBV Technologies’ Peanut Allergy Treatment Wins FDA Breakthrough Therapy Designation

April 14, 2015
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The FDA has awarded breakthrough therapy designation for peanut allergy treatment to DBV Technologies’ Viaskin Peanut. It marks the first time the FDA granted the designation for a food allergy, the France-based company says.

The designation is meant to hasten the development and review process for treatments of serious or life-threatening diseases or conditions.

Using epicutaneous immunotherapy, a treatment that delivers an allergen directly to the skin’s outer layers to springboard the immune system, Viaskin’s electrostatic patch targets antigen-presenting cells without enabling the antigen to seep into the bloodstream, the company says.

DBV reported positive Phase IIb outcomes with the Viaskin Peanut, demonstrating that pediatric patients responded positively and significantly to 250 micrograms of the treatment. Clinical data indicated an outstanding safety profile across all age groups, the company claims. DBV plans a Phase III trial.

The company also is undertaking Phase I testing for milk allergies and pre-clinical trials to evaluate treatment against dust mite allergies.

Pediatric food allergies rose by an estimated 50 percent between 1997 and 2011, according to a 2013 CDC study. Peanut allergies are among the most common food allergies in the U.S. — Jason Scott