Press release
United Therapeutics Announces First Patient Enrolled in Phase 3 TETON 2 Study of Tyvaso in Patients With Idiopathic Pulmonary Fibrosis
Second registration study of Tyvaso® (treprostinil) Inhalation Solution for patients with IPF SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS
About this update from United Therapeutics Corporation
[{"type":"text","content":"\nSecond registration study of Tyvaso® (treprostinil) Inhalation Solution for patients with IPF\n\n SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--\nUnited Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the first patient has enrolled in the phase 3 TETON 2 study which will evaluate Tyvaso in 396 adult patients with idiopathic pulmonary fibrosis (IPF) at sites outside the United States and Canada. This second registration study is part of the broader global TETON program evaluating Tyvaso for the treatment of IPF. The 52-week study will evaluate the impact of Tyvaso on a key prognostic indicator for IPF known as forced vital capacity (FVC). IPF is a progressive lung disease characterized by the loss of the ability of the lungs to transfer oxygen into the blood, ultimately resulting in respiratory failure and death.\n\n“Despite the availability of two approved products in this therapeutic category, there remains a critical unmet need in IPF,” said Steven Nathan, M.D., Medical Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital in Falls Church, Virginia, who is also chair of the TETON program steering committee. “As is now widely known in the pulmonology community, the safety data collected from the INCREASE study showed a positive impact of inhaled treprostinil on FVC in IPF patients with pulmonary hypertension. In follow-up to this, the TETON 1 and TETON 2 studies have been designed to further investigate the potential antifibrotic effects of inhaled treprostinil in IPF patients.”\n\nTyvaso is currently approved by the U.S. Food and Drug Administration (FDA) to treat both pulmonary arterial hypertension and pulmonary hypertension (PH) associated with interstitial lung disease (PH-ILD). The PH-ILD indication, which includes patients with PH associated with IPF, was added to the Tyvaso label in March 2021 based on the successful results of the INCREASE study. Tyvaso is not approved in any jurisdiction for use for IPF patients without documented PH. Additionally, Tyvaso DPI® (treprostinil) inhalation powder is not being evaluated in the TETON program.\n\n“The expansion of the TETON program demonstrates our excitement about the potential for Tyvaso in IPF,” said Peter Smith, Pharm.D., United Therapeutics’ Vice President of Global...