Therapy Areas: Inflammatory Diseases
US FDA grants orphan drug designation to Reata Pharmaceuticals' bardoxolone methyl
7 June 2019 -

The United States Food and Drug Administration (FDA) has granted orphan drug designation to Reata Pharmaceuticals, a clinical-stage biopharmaceutical company, for its bardoxolone methyl (bardoxolone) intended for the treatment of autosomal dominant polycystic kidney disease (ADPKD), it was reported yesterday.

Orphan drug status is granted to treatments for diseases that affect fewer than 200,000 people in the United States and offer specific incentives for the development of therapies intended for the treatment, diagnosis, or prevention of rare diseases. Such designation will provide Reata with certain development incentives, including tax credits for clinical testing, exemption from a prescription drug user fee, and seven years of market exclusivity.

Warren Huff, Reata's chief executive officer and president, said, 'Obtaining orphan drug designation for bardoxolone for the treatment of ADPKD is an important milestone for Reata. This is the third orphan drug designation obtained for bardoxolone in the United States for the treatment of diseases characterised by mitochondrial dysfunction and inflammation, and it is the second designation for the treatment of patients with rare forms of chronic kidney disease.'