Viatris and Theravance Biopharma say that a Phase 3 trial of Yupelri revefenacin inhalation solution for the treatment of COPD conducted in China met its primary endpoint and that Viatris expects to file a marketing application for Yupelri in China next year. Yupelri has been approved for the treatment of COPD in the US since 2018.
In 2015, Viatris (then Mylan) and Theravance Biopharma signed a development and commercialization agreement for nebulized revefenacin (then called TD-4208) that excluded China. The companies expanded that agreement in 2019 to add China, Hong Kong, Macau, and Taiwan.
According to the companies, the study enrolled 258 patients with moderate-to-severe COPD who received either a once-daily 175 μg dose of nebulized Yupelri or placebo over a 12-week period. At 24 hours following the last dose, the mean difference in change of trough FEV1 from baseline was 150.9 ml. The announcement notes that the results, including safety and tolerability data, are similar to the results from a US Phase 3 trial of Yupelri with the same study design.
Viatris President Rajiv Malik commented, “We are pleased with the positive topline results of our Phase 3 clinical results for Yupelri in China. The strength of the data and the primary endpoint analysis, which is consistent with our US 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.”
Theravance Biopharma CEO Rick E. Winningham said, “Given its novel profile, we and Viatris share a commitment to make Yupelri available for as many COPD patients as possible, particularly those who stand to benefit from nebulized therapy, and we commend Viatris on the execution of this study. The consistent lung function improvement demonstrated in this study supports the use of LAMA therapy as foundational in a range of patients and we are encouraged that COPD patients in China may soon have the opportunity to benefit from a new, valuable treatment option.”
Read the Viatris and Theravance Biopharma press release.
