The placebo-controlled trial analysed the safety and efficacy of revefenacin against that of placebo in moderate to very severe COPD patients in China.
The findings showed that Yupelri met the trial’s primary efficacy endpoint by demonstrating a statistically significant rise in trough forced expiratory volume in one second (FEV₁) versus placebo.
When trough FEV₁ was evaluated 24 hours after the last dose at week 12, the primary efficacy analysis showed a mean difference of 150.9ml versus placebo.
The treatment’s safety and tolerability profile was reported to be consistent with the adverse events that are printed on the product’s package insert in the US.
Yupelri is a long-acting muscarinic antagonist offered as a once-a-day nebulised dose.
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Viatris president Rajiv Malik said: “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 nebulised 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 nebulised 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.”