United Therapeutics seeks IPF approval for Tyvaso

• United Therapeutics submitted an sNDA to the FDA for nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF).
• The FDA accepted the application, with a review decision expected in late April 2027.
• Phase 3 TETON studies showed statistically significant improvement in forced vital capacity compared with placebo.

United Therapeutics Corporation (NASDAQ:UTHR) announced that the FDA accepted its supplemental New Drug Application for nebulized Tyvaso (treprostinil) Inhalation Solution as a potential treatment for idiopathic pulmonary fibrosis (IPF).

The FDA review is expected to be completed in late April 2027, while nebulized Tyvaso remains investigational for IPF and has not been approved by the FDA for this indication.

The application was supported by Phase 3 TETON-1 and TETON-2 trial results, where combined analyses showed nebulized Tyvaso achieved a statistically significant improvement in absolute forced vital capacity compared with placebo, with a treatment difference of 111.8 mL at week 52 and a p-value below 0.0001.

United Therapeutics stated that the FDA and European Medicines Agency have granted orphan designation for treprostinil in IPF.

United Therapeutics develops therapies for serious and life-threatening diseases, including pulmonary hypertension, pulmonary fibrosis, and other conditions involving the lungs and cardiovascular system.

The TETON clinical program includes two Phase 3 randomized, double-blind, placebo-controlled studies evaluating nebulized Tyvaso in IPF patients, while the company is also studying the therapy in progressive pulmonary fibrosis through the TETON-PPF program.