Urovant Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA for vibegron is supported by an extensive clinical development program, which included over 4,000 patients with OAB. In a pivotal efficacy and safety study, once-daily 75mg vibegron met all primary and key secondary efficacy endpoints, and demonstrated a favorable safety profile.
“Our NDA submission for vibegron is a significant milestone for our company and brings us one step closer to potentially providing a new oral therapy to a highly dissatisfied market,”
said Keith Katkin, Chief Executive Officer of Urovant.
“The symptoms of overactive bladder affect over 30 million people in the U.S. Vibegron, if approved next year, would be the first new branded prescription drug for the treatment of OAB in nearly a decade.”