United Therapeutics: TETON 1 study of nebulized Tyvaso for IPF fully enrolled

United Therapeutics (UTHR) announced full enrollment of the TETON 1 study evaluating the use of Tyvaso or treprostinil, inhalation solution or nebulized Tyvaso, for the treatment of idiopathic pulmonary fibrosis IPF. The TETON 1 study enrolled 598 patients and is part of the three-study global TETON clinical trial program evaluating the use of inhaled treprostinil in IPF and a similar condition, progressive pulmonary fibrosis PPF . “Completing enrollment in this trial brings us one step closer to potentially delivering a transformative and much needed treatment option for this vulnerable group of patients living with IPF,” said Peter Smith, Pharm. D., Vice President, Product Development at United Therapeutics and the lead for the global TETON program. The TETON program in IPF and PPF was prompted by data from the INCREASE study of nebulized Tyvaso for the treatment of pulmonary hypertension associated with interstitial lung disease PH-ILD , which demonstrated in a post-hoc analysis that treatment with nebulized Tyvaso resulted in significant improvements in percent predicted forced vital capacity at weeks 8 and 16, with subjects having an underlying etiology of IPF showing the greatest improvement…If the TETON 1 and TETON 2 trials are successful, United Therapeutics intends to use the data from the studies to support a regulatory filing with the FDA to add IPF to the labeled indications for nebulized Tyvaso. In Europe, where Tyvaso is not an approved product, we plan to work with our international distributor, Grupo Ferrer Internacional, S.A., to support a marketing authorization application with the European Medicines Agency for nebulized Tyvaso to treat IPF.