FDA grants Breakthrough Therapy Designation for Viaskin Peanut for the treatment of peanut allergy in children

DBV Technologies has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Viaskin® Peanut for children with peanut allergies.

Viaskin is an electrostatic patch, based on Epicutaneous Immunotherapy, or EPIT®, which administers an allergen directly onto the superficial layers of the skin to activate the immune system by specifically targeting antigen-presenting cells without allowing passage of the antigen into the bloodstream.

DBV is actively preparing the launch of its Phase III trial of Viaskin Peanut in children suffering from peanut allergy, in close coordination with the FDA. The FDA granted this Breakthrough Therapy Designation after DBV reported positive Phase IIb results with Viaskin Peanut.

The Viaskin Peanut Efficacy and Safety trial, or VIPES, is a Phase IIb study demonstrating that Viaskin Peanut 250 μg improved the peanut allergy disease in children, as measured by a clinically significant endpoint. Available safety data from past and ongoing studies with Viaskin Peanut demonstrate an excellent safety profile in all age groups.

Viaskin Breathrough designation highlights the urgent need to provide safe pharmaceutical treatments for patients suffering from food allergies

Dr Pierre-Henri Benhamou, M.D., Chairman and CEO of DBV Technologies said, “We are truly honoured to be the first company to receive this FDA designation in food allergies. This is an historical event for the peanut allergy patients, caretakers and clinicians that have long awaited for a treatment for this severe disease.” Dr Benhamou continued, “In addition to the Fast Track designation already granted in December 2011, we are thankful for the FDA’s decision to acknowledge the clinical relevance and importance of Viaskin Peanut. This Breakthrough designation highlights the urgent need to find a treatment for this life-threatening disease, and we are committed to bringing Viaskin Peanut to the market as quickly as possible.”

For more information about DBV Technologies, please visit www.dbv-technologies.com.