DBV Technologies' (DBVT) Viaskin Milk Receives FDA Fast Track Designation

September 21, 2016 6:14 AM EDT
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DBV Technologies (Nasdaq: DBVT) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viaskin Milk, the Company’s investigational treatment for pediatric patients two years of age and older with Immunoglobulin E (IgE)-mediated cow’s milk protein allergy (CMPA), currently under clinical investigation in a Phase IIb trial. There are currently no approved treatments for CMPA, the most common food allergy in infants and young children. Fast Track is a process designed by the FDA to facilitate the development, expedite the review of drugs to treat serious conditions and fill an unmet medical need.1

Chief Development Officer of DBV Technologies, Laurent Martin, said, “This achievement reinforces our commitment to bringing novel therapies to food allergic patients. We are the first to announce Fast Track designation in this indication, and Viaskin Milk is DBV’s second product candidate to secure an expedited review designation by the FDA.” Mr. Martin continued, “CMPA is one of the most common food allergies in children, and a life-threatening disease for which there currently is no approved treatment, representing a major public health challenge. We look forward to working closely with the FDA throughout the development process of Viaskin Milk.”

Results from the ongoing Phase IIb portion of the Viaskin MILk Efficacy and Safety (MILES) Phase I/IIb study of Viaskin Milk in IgE-mediated CMPA children and adolescents ages two to 17 are expected in the second half of 2017. A Phase II clinical trial assessing Viaskin Milk for the treatment of milk allergy-induced Eosinophilic Esophagitis (EoE) in children ages four to 17 is also ongoing in collaboration with the Children’s Hospital of Philadelphia.

“This milestone underscores the high unmet need for patients suffering from CMPA. Viaskin Milk could potentially bring the first approved treatment to patients suffering from the debilitating burden of CMPA, and we welcome this FDA decision." said Alan Kerr, Senior Vice President, Global Regulatory Affairs of DBV Technologies.

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