DBV Tech Gets FDA Breakthrough Therapy Designation For Viaskin Peanut

(RTTNews) - DBV Technologies (DBVT) announced that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation to Viaskin Peanut for children.

Breakthrough Therapy Designation is intended to expedite the development and review of drugs/biological products for serious or life-threatening diseases or conditions, such as peanut allergy.

DBV said it is actively preparing the launch of its Phase III trial of Viaskin Peanut in Children, suffering from peanut allergy, in close coordination with the US 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 microgrammes 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.