United Therapeutics’ Tyvaso cleared another key late-stage milestone in idiopathic pulmonary fibrosis after a second Phase III trial hit its endpoints. The company is positioning for a potential priority review in a supplemental NDA, aiming to translate continued efficacy signal into earlier regulatory acceleration. In the trial results, Tyvaso (treprostinil) showed superiority over placebo on change in absolute forced vital capacity and reduced the risk of clinical worsening. United said the safety profile remained well-tolerated, supporting a path to broader adoption in 2027 if regulators accept the expanded indication package.
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