Theravance Announces Publication of YUPELRI® (revefenacin) Area Under the Curve Spirometry Analysis in the International Journal of Chronic Obstructive Pulmonary Disease

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[{"type":"text","content":"DUBLIN, Oct. 18, 2024 /PRNewswire/ -- Theravance Biopharma, Inc. (\"Theravance Biopharma\" or the \"Company\") (NASDAQ: TBPH) today announced the publication of a sub-study of the pivotal 12-week, randomized, registrational revefenacin Phase 3 trials (Trials 0126 [NCT02459080] and 0127 [NCT02512510]) for YUPELRI, the first and only FDA approved once-daily nebulized long-acting muscarinic antagonist (LAMA), evaluating the area under the curve (AUC) lung function effects in moderate-to-very-severe chronic obstructive pulmonary disease (COPD) patients. These data and analyses, published in the International Journal of Chronic Obstructive Pulmonary Disease, reinforce that YUPELRI provides consistent and durable improvements in lung function, as compared with placebo, over a full 24-hours.\n\n \n \n \n \n \n \n\n \n\"Where previous data showed that revefenacin significantly improved peak and trough FEV1 at Day 85 compared with placebo in patients with moderate-to-very-severe COPD, this subset post-hoc analysis depicts a more comprehensive view of 24-hour bronchodilation as assessed by examining AUC over multiple time periods,\" said Dr. Donald A. Mahler, Emeritus Professor of Medicine at Geisel School of Medicine at Dartmouth in Hanover, NH and Pulmonologist and Respiratory Director at Valley Regional Hospital in Claremont, NH. \"It provides additional valuable clinical insight into the duration and consistency of revefenacin over the entire dosing interval.\"\nDr. Blake LeMaster, Assistant Professor of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, commented, \"Importantly, this drug also exhibits a substantial peak response as well as bronchodilation over the initial 2-hour period as exhibited by FEV1 AUC 0-2H.\" He added, \"Clinically meaningful bronchodilation was seen within the first 15 minutes of administration, persisting over the 24-hour duration during which patients underwent serial spirometry. These data demonstrate that revefenacin can provide rapid and prolonged bronchodilation with just a single dose.\"\nKey Study Findings:\nAnalysis of a retrospective, pooled sub-study from Phase 3 Studies 0126 and 0127 demonstrated that revefenacin (n = 50) improved bronchodilation versus placebo (n = 47) in patients with moderate-to-very-severe COPD when assessed by FEV1 AU...

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