Posted by Michael Wonder on 30 Jan 2018
Theravance Biopharma and Mylan announce FDA acceptance of new drug application for revefenacin (TD-4208) in adults with chronic obstructive pulmonary disease
29 January 2018 - FDA assigns PDUFA target action date of 13 November 2018.
Theravance Biopharma and Mylan today announced that the U.S. FDA has accepted for review the companies' recently submitted new drug application for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist. If approved, revefenacin would be the first once-daily, nebulised bronchodilator for the treatment of chronic obstructive pulmonary disease. The FDA has assigned a Prescription Drug User Fee Act target action date of 13 November 2018, and indicated that it does not currently plan to convene an advisory committee meeting to discuss the application.
Theravance Biopharma and Mylan previously reported that in two replicate pivotal Phase 3 efficacy studies, revefenacin demonstrated statistically significant and clinically meaningful improvements as compared to placebo in trough forced expiratory volume in one second and in overall treatment effect on trough FEV1 after 12 weeks of dosing.
