Posted by Michael Wonder on 13 Nov 2017
Theravance Biopharma and Mylan submit new drug application to FDA for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
13 November 2017 - Filing supported by positive results from two pivotal Phase 3 efficacy studies and one 12 month Phase 3 safety study.
Theravance Biopharma and Mylan today announced the submission of a new drug application to the U.S. FDA for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist as a once-daily, nebulized bronchodilator in development for the treatment of chronic obstructive pulmonary disease.
The application is supported by the companies' Phase 3 program for revefenacin, which consisted of two replicate pivotal Phase 3 efficacy studies and a 12-month, open-label, active comparator safety study.
