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Viatris and Theravance Biopharma Announce Positive Top-Line Results from YUPELRI® (revefenacin) Phase III Trial in China for the Treatment of Chronic Obstructive Pulmonary Disease (COPD)
Top-line results from Phase III study in China demonstrate the efficacy and safety profile of YUPELRI in patients with COPD PITTSBURGH and DUBLIN, Nov. 13,
About this update from Viatris Inc.
[{"type":"text","content":"Top-line results from Phase III study in China demonstrate the efficacy and safety profile of YUPELRI in patients with COPD\nPITTSBURGH and DUBLIN, Nov. 13, 2023 /PRNewswire/ -- Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced positive results from the YUPELRI® (revefenacin) Phase III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of YUPELRI, a once-daily nebulized long-acting muscarinic antagonist (LAMA) for the maintenance treatment of patients with COPD. Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV1 (forced expiratory volume in one second) versus placebo. The results are comparable to those from studies of the same design used for U.S. registration and provide support for a regulatory filing in China anticipated to occur in mid-2024.\n\n \n \n \n \n \n \n\n \nTop Line Results Highlights: \nA total of 258 patients enrolled with 257 included in safety and full analysis sets. Both groups were well balanced for baseline characteristics with 129 treated with YUPELRI and 128 treated with placebo.Study population was moderate to very severe COPD patients with mean baseline FEV1 approximately 50% predicted. Approximately two-thirds of patients remained on long-acting beta-2 agonist/inhaled corticosteroids throughout the study.Primary efficacy analysis of change from baseline in trough FEV1 measured 24 hours after the final dose at week 12 detected a mean (95% confidence intervals) treatment difference of 150.9 (104.1, 197.7) mL compared to placebo.Safety and tolerability profile assessed by summary of adverse events consistent with U.S. package insert.Viatris President Rajiv Malik said, \"We are pleased with the positive top-line results of our Phase III clinical results for YUPELRI in China. The strength of the data and the primary endpoint analysis, which is consistent with our U.S. clinical data, firmly supports a comparable efficacy and safety profile of YUPELRI. With this data, we look forward to progressing our regulatory application in China and continue to believe, when approved, a once-daily nebulized revefenacin product will be an important therapeutic option for the millions of patients in the region with COPD.\"\n\"Given it...