United Therapeutics (UTHR) said Tuesday that a phase 3 study evaluating the use of nebulized Tyvaso to treat idiopathic pulmonary fibrosis, of IPF, has reached full enrollment.
The 598-patient Teton 1 study is part of three-study clinical trial program assessing the use of inhaled treprostinil in IPF and a similar condition of progressive pulmonary fibrosis, the biotechnology company said.
Enrollment for the Teton 2 trial, which is evaluating the use of Tyvaso in IPF in patients outside the US and Canada was completed in July last year, with top-line data expected in the second half of this year, it said.
If both studies are successful, United Therapeutics said the data will be used to support a filing for the US Food and Drug Administration's approval to add IPF to the labeled indications for nebulized Tyvaso.
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