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United Therapeutics Corporation Announces FDA Acceptance of Supplemental New Drug Application for Nebulized Tyvaso® to Treat Idiopathic Pulmonary Fibrosis

UTHR
  • United Therapeutics announced that the FDA accepted the supplemental New Drug Application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF).
  • The company anticipates the FDA review to be complete in late April 2027.
  • Nebulized Tyvaso remains investigational for IPF treatment & has not yet received FDA approval for this indication.
  • If approved, nebulized Tyvaso would be the first & only inhaled anti-fibrotic treatment for IPF.
  • The filing is based on positive results from the phase 3 TETON-1 & TETON-2 studies.
  • Combined analyses demonstrated statistically significant superiority over placebo for the change in absolute forced vital capacity (FVC) by 111.8 mL from baseline to week 52.
  • Secondary endpoints showed statistical significance for reduced risk of clinical worsening, reduced risk of acute IPF exacerbation, & improvements in quality of life (K-BILD) & diffusion capacity (DLCO).
  • Both the FDA & the European Medicines Agency have granted orphan designation for treprostinil to treat IPF.
  • The TETON-1 study enrolled patients in the US & Canada, while TETON-2 enrolled patients outside these regions.
  • An ongoing open-label extension study (TETON-OLE) is evaluating long-term safety & tolerability in patients with fibrotic lung disease.
  • The TETON-PPF study evaluating use in progressive pulmonary fibrosis (PPF) has completed enrollment.
  • IPF is a progressive scarring disease of the lungs estimated to affect at least 100,000 people in the US.
  • Current approved indications for Tyvaso include pulmonary arterial hypertension (PAH) & pulmonary hypertension associated with interstitial lung disease (PH-ILD).
  • Safety warnings include risks of hypotension, bleeding, & acute bronchospasm in patients with asthma or COPD.
  • Common adverse reactions in PAH patients included cough, headache, throat irritation, nausea, flushing, & syncope.
  • The press release was issued as of September 2, 2026, by United Therapeutics Corporation.