First COPD Patient Enrolled in Phase 4 Study of Yupelri vs. Spiriva

A first patient has been enrolled in a Phase 4 study of the effectiveness of Yupelri (revefenacin) against Spiriva (tiotropium) in improving lung health in adults with severe chronic obstructive pulmonary disease (COPD). The respective safety of these two approved, once-daily COPD maintenance treatments will also be evaluated. Yupelri, developed…

FDA Approves Yupelri as New Treatment for Adults with COPD

Theravance Biopharma and Mylan announced that the U.S. Food and Drug Administration (FDA) approved their New Drug Application (NDA) for revefenacin (TD-4208) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). The therapy will be marketed as an inhalation solution with the brand name Yupelri. The…

FDA Accepts New Drug Application for Revefenacin in Treatment of COPD

The U.S. Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) submitted by Theravance Biopharma and Mylan for their collaborative compound revefenacin (TD-4208), a bronchodilator for the treatment of chronic obstructive pulmonary disease (COPD) in adults. The two pharmaceutical companies are aiming to develop and…

Positive Phase 3 Trial Data of COPD Therapy Revefenacin Reported by Theravance and Mylan

Theravance Biopharma and Mylan recently reported positive Phase 3 trial data on the effectiveness of the drug revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD). Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and the first once-daily nebulized bronchodilator in development to treat COPD. The drug will be…

Theravance/Mylan Initiate Phase III Clinical Trial of Revefenacin for COPD

Theravance Biopharma, Inc. and Mylan MYL recently announced the commencement of a new phase III clinical program to evaluate revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) being developed to treat chronic obstructive pulmonary disease (COPD). The Phase III clinical program involves two replicate, randomized, placebo-controlled, double-blind, parallel-group,…