The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for vibegron (Urovant Sciences) for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Vibegron is an oral, once-daily, small molecule beta-3 adrenergic agonist. The application is supported by data from an extensive clinical development program involving over 4000 patients with OAB. Specifically, the program consists of the pivotal phase 3 EMPOWUR study in which 1518 patients were randomized to receive vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily for 12 weeks.
Findings from EMPOWUR showed that vibegron achieved a statistically significant reduction in daily urge urinary incontinence episodes (P <.0001) and daily micturitions (P <.001) as early as 2 weeks compared with placebo (co-primary end points). Vibegron also maintained statistically significant efficacy at all timepoints through the end of the study. Moreover, vibegron was statistically superior to placebo for key secondary end points including the number of urgency episodes, volume per micturition, and proportion of incontinent patients with a ≥75% reduction in urge-incontinence episodes (all P <.01).
In a 40-week extension study, vibegron improved treatment benefit on key OAB symptoms. At week 52, 61% of vibegron-treated patients achieved at least a 75% reduction in daily urge urinary incontinence episodes, while 41% reported no urge urinary incontinence episodes.
With regard to safety, vibegron demonstrated a favorable long-term safety and tolerability profile. The most common treatment-emergent adverse reactions were headache, nasopharyngitis, diarrhea, and nausea.
“FDA acceptance of our NDA for vibegron for the treatment of patients with OAB represents another important milestone for Urovant, and we look forward to working with the FDA during the NDA review period,” said Dr Cornelia Haag-Molkenteller, Chief Medical Officer of Urovant Sciences. “Vibegron, if approved, would be the first new branded prescription drug for the treatment of OAB in nearly a decade and would offer these suffering patients another potential treatment option.”
The Company is also investigating vibegron for the treatment of OAB in men with benign prostatic hyperplasia (BPH) and for the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
A Prescription Drug User Fee Act (PDUFA) target date of December 26, 2020 has been assigned to this application.