Reata Pharmaceuticals’ bardoxolone methyl receives FDA Orphan Drug Designation in Pulmonary Arterial Hypertension

Industry News

The FDA granted Reata Pharmaceuticals’ bardoxolone methyl Orphan Drug Designation (ODD) for pulmonary arterial hypertension (PAH).  Reata Pharmaceuticals is a biopharmaceutical company based in Irving, TX that develops medicines for difficult-to-treat diseases. PAH is a progressive disease characterized by abnormally high blood pressure in the pulmonary artery.  It worsens over time and is life-threatening because the pressure in a patient’s pulmonary arteries rises to dangerously high levels, putting a strain on the heart. Additionally, PAH involves skeletal muscle dysfunction that contributes to the exercise intolerance observed in PAH patients.  There is no cure for PAH currently. In preclinical studies, bardoxolone methyl has demonstrated potent antioxidant, anti-inflammatory, and bioenergetic properties, which may lead to improved exercise tolerance in patients. Bardoxolone methyl is currently undergoing evaluation in a multi-center, double-blind, randomized, dose-ranging, placebo-controlled Phase II trial.


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