Curie Brief
Turn on cookies to sign in
Signing in saves your progress to your Curie account. We can only do that with cookies on — turn them on to continue.
News
The FDA has accepted United Therapeutics' application to expand nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF), backed by data from the phase 3 TETON-1 and TETON-2 trials. If approved, it would be the first inhaled antifibrotic for IPF — a disease currently managed only with oral therapies. A decision is expected by late April 2027.
The FDA has accepted United Therapeutics' supplemental new drug application (sNDA) for nebulized Tyvaso (treprostinil) as a treatment for idiopathic pulmonary fibrosis (IPF), with a target action date of late April 2027. If approved, it would be the first inhaled antifibrotic for IPF — a meaningful shift from the current standard of oral-only therapies like nintedanib and pirfenidone.
The application is backed by data from the replicate phase 3 TETON-1 and TETON-2 trials, which together enrolled 1,191 patients across North America and internationally. Both trials demonstrated that inhaled treprostinil significantly slowed lung function decline compared to placebo, with consistent benefits seen whether or not patients were already on background antifibrotic therapy.
By the Numbers:
Why it matters: IPF is a progressive, life-threatening lung disease with limited treatment options. An inhaled therapy that targets fibrotic, vascular, and inflammatory pathways simultaneously could offer patients — including those already on oral antifibrotics — a meaningful new tool to slow disease progression.
