United Therapeutics announced that the Phase 3 TETON-2 trial of nebulized Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis met its primary efficacy endpoint, demonstrating a 95.6 mL change in absolute FVC from baseline to week 52. Several secondary endpoints were also met, including statistically significant improvements compared to placebo in change in baseline for precent predicted FVC and patient-reported quality of life.
The FDA approved Tyvaso inhalation solution for the treatment of pulmonary arterial hypertension in July 2009 and in March 2021, approved use of the inhalation solution for the treatment of pulmonary hypertension with interstitial lung disease (PH-ILD) in March 2021.
The TETON-2 study was initiated in October 2022, and enrolled 597 IPF patients who received either nebulized Tyvaso or nebulized placebo 4 times per day over 52 weeks. Another Phase 3 trial of Tyvaso inhalation solution in IPF patients, TETON-1, was initiated in 2021 and is still underway, with top-line data expected to be available by mid-2026. United Therapeutics says that it intends to meet with the FDA before the end of 2025 “to discuss ways to potentially expedite the regulatory review process when TETON-1 results are available.“
United Therapeutics Chairperson and CEO Martine Rothblatt commented, “It is a profound honor to witness the power of scientific innovation realized for patients in need. TETON-2’s successful outcome affirms the anti-fibrotic power of Tyvaso. We have unlocked new hope for patients with IPF and their families.”
Senior VP, Product Development, Peter Smith said, “These overwhelmingly positive data send a clear signal of the potential benefits of Tyvaso for patients with IPF. We are deeply grateful to every patient who participated in this important study and the investigators whose dedication made this milestone possible. These results have the potential to reshape the treatment of IPF, extending new opportunities to a much broader patient population than ever before.”
Read the United Therapeutics press release
