FDA accepts new drug application for overactive bladder agent

March 24, 2020

The FDA has accepted for review Urovant Sciences’ New Drug Application for once-daily 75 mg vibegron for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The FDA has accepted for review Urovant Sciences’ New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The NDA has been assigned a Prescription Drug User Fee Act goal date of Dec. 26, 2020. In addition, the FDA has indicated that it is not currently planning to hold an Advisory Committee meeting to discuss the application, Urovant Sciences said.

Vibegron is an oral, once-daily small molecule beta-3 agonist that is being evaluated for OAB. Urovant Sciences reported positive data from the vibegron 12-week, phase III pivotal EMPOWUR study and demonstrated favorable longer-term efficacy, safety, and tolerability in a 40-week extension study.

Results from EMPOWUR were published in the Journal of Urology (Feb. 18, 2020 [Epub ahead of print]). The double-blind, placebo-controlled 12-week trial, in patients with OAB, studied vibegron 75 mg once-daily compared to placebo and included an active control. In the trial, vibegron achieved rapid onset of action at 2 weeks in both co-primary endpoints and daily urgency episodes, and statistically significant efficacy was maintained at all timepoints measured through the end of the study.

Vibegron is also being evaluated for treatment of OAB in men with BPH and for abdominal pain associated with irritable bowel syndrome.