APR Applied Pharma Research's APR-TD011 granted US FDA Orphan Drug Designation
5 December 2019 -

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation to Switzerland-based APR Applied Pharma Research sa for its investigational drug, code-named APR-TD011, intended for the treatment of Epidermolysis Bullosa (EB), it was reported yesterday.

The product is a hypotonic acid-oxidising solution containing hypochlorous acid in a spray form for topical application, specifically developed for EB. It is to prevent or decrease infections and inflammation through modulation of the wound microenvironment, and thereby accelerate the physiological wound healing.

EB is a group of rare, genetic, life-threatening connective tissue disorders characterized by skin blistering throughout the body as well as severe impact to internal organs.

Paolo Galfetti, APR Applied Pharma Research CEO, said, 'The granting of Orphan Drug Designation in the US highlights the significant need for a drug that could improve the treatment of EB, a debilitating disease that affects the life of half a million people in the US. We believe that APR-TD011 holds great promises for EB patients and their families and the Orphan status will help APR to find expedited pathways to fruition. This designation is also an important milestone and step forward in APR's evolution as we advance our pipeline targeting rare diseases.'