Urovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive Bladder
UROVANT SCIENCES LTD COMMON (UROV)
Last urovant sciences ltd common earnings: 2/13 04:15 pm
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Source: Business Wire
IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today 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,
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