Theravance Biopharma announced that the Phase 4 PIFR-2 study of nebulized Yupelri revefenacin inhalation solution versus Spiriva HandiHaler tiotropium DPI in patients with severe to very severe COPD failed to demonstrate any significant difference in the improvement in lung function between the two arms. The company announced the initiation of the 12-week Phase 4 trial in January 2022. Yupelri was approved by the FDA in 2018 for the treatment of COPD.
Theravance CEO Rick E Winningham commented, “While the primary endpoint in the Phase 4 PIFR-2 study was not met, Yupelri demonstrated an efficacy and safety profile consistent with its performance in other clinical studies. We appreciate the growth opportunities that lie ahead for Yupelri, which is an important option for COPD maintenance care, and look forward to sharing additional details from PIFR-2 in the future, following additional data analyses.”
Read the Theravance Biopharma press release.
