UROV - Urovant's Gemtesa wins FDA nod for overactive bladder

The FDA has approved Urovant Sciences' ([[UROV]] -0.03%) Gemtesa (vibegron) for the treatment of overactive bladder, according to a posting to the agency's website.Last month the company announced positive data from long term study evaluating vibegron that showed 61% of 143 vibegron-treated patients had a ?75% reduction and 40.8% showed a 100% reduction in urge urinary incontinence.Though topline data from vibegron Phase 2 study in irritable bowel syndrome, failed to meet the primary endpoint with 40.9% of vibegron IBS-D patients achieving at least a 30% improvement in abdominal pain, compared to 42.9% in the placebo group.

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Urovant's Gemtesa wins FDA nod for overactive bladder