Theravance Biopharma and Mylan have announced that a 12-month Phase 3 safety study of nebulized revefenacin (TD-4208) showed that the drug was well tolerated, with low rates of adverse events and serious adverse events that were comparable to a standard of care treatment arm.
The 52-week safety study compared 2 doses of revefenacin to tiotropium. Half of the patients in the study were also taking other treatments such as a LABA or a LABA/ICS combination for COPD.
Theravance Biopharma Chief Medical Officer Brett Haumann commented, “The data from this 12-month safety study build on our observations from the previous three-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. 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 3 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 added, “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.”
Read the Theravance Biopharma and Mylan press release.
