Reata Pharma's Omaveloxolone Gets FDA Orphan Drug Designation To Treat FA

(RTTNews) - Reata Pharmaceuticals, Inc. (RETA), a clinical-stage biopharmaceutical company, announced Thursday that the U.S. Food and Drug Administration has granted Orphan Drug Designation to omaveloxolone for the treatment of Friedreich's ataxia.

Friedreich's ataxia or 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.

Earlier this month, Reata released positive data from Part 1 of the Company's Phase 2 trial of omaveloxolone for the treatment of FA.

The Company expects to initiate Part 2 of MOXIe during the second half of 2017.

Warren Huff, Chief Executive Officer of Reata, SAID, "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."