Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to bardoxolone methyl (bardoxolone) for the treatment of autosomal dominant polycystic kidney disease (ADPKD).
ADPKD is the most common inherited form of kidney disease affecting approximately 140,000 patients in the United States. It is characterized by the development of pathologic fluid-filled cysts throughout the kidneys, which leads to organ enlargement and chronic kidney disease (CKD). Despite standard of care treatment, approximately 50% of these patients will progress to end-stage kidney disease and require dialysis or a kidney transplant by 60 years of age.
“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 characterized by mitochondrial dysfunction and inflammation, and it is the second designation for the treatment of patients with rare forms of CKD,” said Warren Huff, Reata’s Chief Executive Officer and President. “We believe that, if approved, bardoxolone may prove to be a meaningful new treatment option for patients with ADPKD.”
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