DBV Technologies Receives FDA Breakthrough Therapy Designation for Peanut Allergy Treatment

Clinical-stage biopharmaceutical company, DBV Technologies, announced that FDA has granted breakthrough therapy designation to Viaskin Peanut for the treatment of peanut allergy. The designation was granted following positive Phase IIb results demonstrating that Viaskin Peanut 250 mcg improved peanut allergy disease in children, as measured by a clinically significant endpoint. DBV Technologies is currently preparing for Phase III evaluation of Viaskin Peanut.  

Viaskin is an electrostatic patch, based on epicutaneous immunotherapy (EPIT), which delivers an allergen onto the skin. Antigen-presenting cells are targeted to activate the immune system without allowing passage of the antigen into the bloodstream. The patch has shown good safety profile in past and ongoing studies.