Theravance Biopharma has announced the initiation of a Phase 4 study of Yupelri revefenacin inhalation solution, which was approved by the FDA in 2018 for the treatment of COPD. The PIFR-2 study, which is expected to enroll 366 patients with severe to very severe COPD, will compare Yupelri to Spiriva HandiHaler tiotropium DPI over 12 weeks. Topline results are expected in the first quarter of 2023.
According to the announcement, “Success in this study is intended to capture more of Yupelri’s addressable market and further strengthen its competitive advantage.” Theravance Biopharma is partnered with Viatris on development and commercialization of Yupelri, and the companies co-promote the inhalation solution.
Theravance Biopharma CEO Rick E Winningham commented, “Yupelri, discovered and developed by Theravance, is one of the key pillars of value creation for the go-forward organization. We, and our partner Viatris, believe we have just scratched the surface of Yupelri’s contribution to the COPD community. The enrollment of the first patient in the Phase 4 PIFR-2 study demonstrates, through continued investment in controlled clinical studies, our commitment to provide healthcare professionals with the evidence needed to design personalized treatment plans in order to make better informed decisions for their COPD patients.”
Read the Theravance Biopharma press release.