FDA labeling for just-approved pulmonary arterial hypertension drug Orenitram (treprostinil) suggests the oral drug could replace United Therapeutics’ other formulations, though it was not specifically studied for that. Company says it was surprised by the approval, which came well ahead of the user fee date, and plans to launch in six months.
United Therapeutics Corp. is planning to set the price for its newly FDA-approved oral pulmonary arterial hypertension drug Orenitram (treprostinil) in line with the injectable and inhaled versions of the product.
A type of prostacyclin therapy, Orenitram was approved on Dec. 20 as a monotherapy for patients who have PAH graded...