Revefenacin: First Global Approval

Revefenacin (YUPELRI™) inhalation solution, a long-acting muscarinic antagonist (i.e. an anticholinergic) developed by Theravance Biopharma and Mylan, is the first and currently the only once-daily, nebulized bronchodilator to be approved in the USA for the treatment of chronic obstructive pulmonary disease (COPD). In November 2018, based on results of three phase III trials, the US Food and Drug Administration granted market authorization to revefenacin for the maintenance treatment of patients with COPD. This article summarizes the milestones in the development of revefenacin leading to this first global approval.