DBV Technologies Gets FDA Fast Track Designation For Viaskin Milk

(RTTNews) - DBV Technologies (DBVT) said that the U.S. Food and Drug Administration 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 or 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.

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.