FDA Approves Reata’s Skyclarys for Friedrich’s Ataxia

The FDA has approved Reata Pharmaceuticals’ once-daily oral drug Skyclarys (omaveloxolone) for the treatment of adults and adolescents 16 years and older with Friedreich’s ataxia, a rare inherited neuromuscular disease.

About 5,000 patients in the U.S. are diagnosed with the disease that progressively robs patients of their mobility and leads to a shortened life span.

The drug received Orphan Drug, Fast Track, and Rare Pediatric Disease designations and the company also gained a priority review voucher, which can be used for a future marketing application or sold to another drugmaker.

The European Medicines Agency is currently reviewing Reata’s marketing authorization application for omaveloxolone.