Urovant Sciences announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application.
“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. “The symptoms of overactive bladder affect over 30 million people in the United States. 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.”