Posted by Michael Wonder on 31 Dec 2019
Urovant Sciences announces submission of new drug application for vibegron for the treatment of overactive bladder
30 December 2019 - Urovant Sciences announced today that it has submitted a new drug application to the U.S. FDA seeking approval of once-daily 75 mg vibegron for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The application for vibegron is supported by an extensive clinical development program, which included over 4,000 patients with overactive bladder.
In a pivotal efficacy and safety study, once-daily 75 mg vibegron met all primary and key secondary efficacy endpoints, and demonstrated a favourable safety profile.
