These data, combined with positive results from two Phase III efficacy studies, support NDA filing planned for fourth quarter of 2017.

Theravance Biopharma and Mylan have announced positive results from a 12-month Phase III safety study of revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) and a proposed once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease (COPD).

The study of 1,055 patients with COPD demonstrated that revefenacin was generally well-tolerated, and no new safety issues were identified. Rates of adverse events (AEs) and serious adverse events (SAEs) were low and comparable to those seen in the standard of care treatment arm.

The data from this 12-month safety study build on our observations from the previous 3-month efficacy studies and suggest that revefenacin has a favorable safety and tolerability profile when dosed chronically, either as a standalone therapy or when taken as an add-on to other COPD therapies including combinations of ICS and LABA," said Brett Haumann, Chief Medical Officer at Theravance Biopharma. "As of today, there are no approved nebulized LAMAs, despite a significant number of COPD patients needing or preferring nebulized therapy for the treatment of their disease. Having achieved positive efficacy and tolerability data in our Phase III program, we and our partner Mylan believe that revefenacin is well positioned to address this important patient need. We remain on schedule to submit the NDA in the fourth quarter of 2017, which is the next step towards our goal of delivering the first once-daily nebulized bronchodilator to the COPD patient community."

Mylan President Rajiv Malik commented: "Our revefenacin collaboration with Theravance Biopharma continues to deliver results at every step along the development path. We are very pleased with the top-line results from the 12-month safety trial and now feel we have all the data necessary to support a successful NDA filing. Should revefenacin receive approval from the FDA, we look forward to introducing this nebulized LAMA, to ensure the treatment has the greatest possible impact on the lives of patients with COPD."