Theravance Biopharma, Mylan report data from pivotal late stage revefenacin trials

Theravance Biopharma, Inc. (NSDQ:TBPH) and Mylan (NSDQ:MYL) touted efficacy and safety data this week from 3-month, pivotal Phase III trials of revefenacin, the 1st nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease.

The 3-month Phase III studies enrolled more than 1,250 patients with moderate to very severe COPD.

The 1st presentation reported that the therapy demonstrated statistically significant and clinically meaningful improvements over placebo in trough forced expiratory volume in 1 second and in overall treatment effect on trough FEV after 12 weeks of dosing.

The 2nd presentation described safety and tolerability data from the 2 trials. Both doses of revefenacin had comparable rates of adverse events to placebo, according to the companies, and low rates of serious adverse events. There were no clinically meaningful differences in blood parameters or electrocardiogram data across all treatment groups. The most commonly reported adverse events across both trials and all treatment groups were exacerbations, cough, dyspnea and headache.

“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,” Theravance Biopharma’s chief medical officer, Dr. Brett Haumann, said in prepared remarks. “We believe that these results position revefenacin favorably as a potentially key therapeutic option for COPD patients if approved, particularly as revefenacin would represent the 1st once-daily nebulized bronchodilator for COPD. We anticipate completing the ongoing Phase III safety trial of revefenacin in mid-2017 with the goal of filing an NDA by the end of 2017.”

Mylan President Rajiv Malik commented, “We continue to be very pleased with the progress of the Phase III revefenacin program, and are excited to have the opportunity to showcase this important data set at ATS for the 1st time,” Mylan president Rajiv Malik added. “According to the GOLD Guidelines for COPD, LAMAs are a cornerstone of therapy for moderate to severe COPD, yet there are currently no nebulized LAMAs available. We believe this product has the potential to help address an unmet medical need for patients. Further, revefenacin represents a key contributor in Mylan’s pipeline of promising respiratory products, and supports the growth of our respiratory franchise. If approved, we believe that we are well-positioned to support the commercial success of this product.”

NEXT: Sunovion Pharmaceuticals touts data for COPD therapies