Revefenacin, a long-acting muscarinic antagonist (LAMA), has shown promising results in a Phase 3 study of COPD patients, reports Healio.
“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 [inhaled corticosteroids] and [long-acting beta-agonists (LABA)],” Brett Haumann, MD, chief medical officer at Theravance Biopharma, said in the release.
“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.”
Read more at www.healio.com