Urovant files for US approval of vibegron for overactive bladder

31 December 2019

Urovant Sciences says it has submitted a New Drug Application (NDA) to the US Food and Drug Administration 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, says Urovant, now a subsidiary of Sumitomo Dainippon Pharma (TYO: 4506), within a new biotech dubbed Sumitovant Biopharma .

Drug licensed from Merck & Co

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