A Phase 3, 52-week, Randomized, Active−Controlled Parallel Group Study to Evaluate the Safety and Tolerability of Nebulized TD−4208 in Subjects With Chronic Obstructive Pulmonary Disease
Phase of Trial: Phase III
Latest Information Update: 29 Jan 2018
At a glance
- Drugs Revefenacin (Primary) ; Tiotropium bromide
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Sponsors Theravance Biopharma
- 29 Jan 2018 According to a Theravance Biopharma media release, the U.S. Food and Drug Administration (FDA) has accepted for review New Drug Application (NDA) of revefenacin for the treatment of chronic obstructive pulmonary disease, and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of November 13, 2018.
- 13 Nov 2017 According to a Theravance Biopharma media release, the company has submitted a New Drug Application (NDA) to the US FDA for revefenacin intended to treat chronic obstructive pulmonary disease (COPD). The application is supported by data from this and two other phase III trials.
- 01 Nov 2017 According to a Theravance Biopharma media release, filing of New Drug Application (NDA) is planned in the fourth quarter of 2017.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History