IRVING, Texas, June 22, 2017 – Reata Pharmaceuticals, Inc. (Nasdaq:RETA) (“Reata” or “the Company”), a clinical-stage biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to omaveloxolone for the treatment of Friedreich’s ataxia.
Friedreich’s ataxia (FA) is an inherited, debilitating, and degenerative neuromuscular disorder that is typically diagnosed during adolescence and can ultimately lead to early death. Patients with FA experience progressive loss of coordination, muscle weakness, and fatigue, which commonly progresses to motor incapacitation and wheelchair reliance. There are no currently approved therapies for the treatment of FA.
“Orphan drug designation serves as an important milestone for our company as it recognizes the promise of omaveloxolone as a potential new treatment for FA. In light of the recent, encouraging clinical data, we are hopeful that omaveloxolone will be the first therapy approved for patients with FA,” said Warren Huff, Chief Executive Officer of Reata.