Mylan N.V and Theravance Biopharma, Inc. (TBPH) reported early Tuesday positive additional efficacy and safety data from a phase 3 study of revefenacin to treat chronic obstructive pulmonary disease (COPD). “These presentations build upon the topline results that we announced last October and further confirm that revefenacin may offer meaningful benefits to patients with moderate to very severe COPD,” said Brett Haumann, chief medical officer at Theravance Biopharma. “We believe that these results position revefenacin favorably as a potentially key therapeutic option for COPD patients if approved.”
Theravance Biopharma and Mylan have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. The companies said they expect to complete the ongoing phase 3 safety trial of revefenacin in mid-2017 with the goal of filing a new drug application by the end of the year.