Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA submission includes data from an extensive clinical development program involving over 4000 patients with OAB. Results from the pivotal 12-week phase 3 EMPOWUR study support the efficacy and safety of vibegron in 1518 patients randomized to receive either vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily. Read more.
Source: MPR, January 2, 2020