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Reata's kidney disease treatment secures orphan designation in EU

The European Commission granted orphan drug designation to Reata Pharmaceuticals Inc.'s bardoxolone methyl to treat Alport syndrome.

Alport syndrome is a rare, genetic form of chronic kidney disease caused by mutations in genes encoding type IV collagen, which is a major structural component of the glomerular basement membrane in the kidney.

The designation was based on the positive opinion from the Committee for Orphan Medicinal Products of the European Medicines Agency.

Orphan designation is granted in Europe to drugs intended to treat life-threatening or chronically debilitating diseases that affect no more than five in 10,000 people in the EU and have no satisfactory treatments available, or where the new therapy potentially has a significant benefit.

In the phase 2 results of a phase 2/3 study, bardoxolone significantly improved kidney function in patients after 36 weeks of treatment.

Irving, Texas-based Reata Pharmaceuticals is a clinical stage biopharmaceutical company, which focuses on identifying, developing, and commercializing product candidates for patients with rare and life-threatening diseases by targeting molecular pathways that regulate cellular metabolism and inflammation.