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Investigational Drug for Epidermolysis Bullosa Receives Orphan Drug Designation

Written by Yourway | December 12, 2019

The U.S. Food and Drug Administration announced that it has granted the Orphan Drug Designation to APR Applied Pharma Research's investigational drug APR-TD011 for the treatment of epidermolysis bullosa, a group of debilitative, genetic connective tissue disorders. The designation will provide a range of benefits, including tax credits, FDA assistance in trial design, and seven years of market exclusivity upon approval. Yourway believes that developing treatments and conducting trials for patients with rare diseases is of critical importance.