Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
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
Vibegron is a once-daily beta-3 adrenergic agonist under investigation for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development of vibegron in patients with OAB and obtain