- 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.
李< ul > < >美国食品和药物管理局已批准Urovant科学”(< a href = " https://seekingalpha.com/symbol/UROV " title =“Urovant科学有限公司”> UROV < / > <字体颜色=“红色”> < /字体> -0.03%)Gemtesa (vibegron)治疗膀胱过动症,根据< a href = " https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process& ApplNo = 213006 "目标=“平等”>发布到该机构的网站< / >。李李< / > < >上个月该公司宣布< a href = " https://seekingalpha.com/news/3637944-urovants-vibegron-shows-durable-effect-in-overactive-bladder " target = "平等" >积极的长期研究数据< / >评估vibegron显示61%的143年vibegron-treated患者减少≥75%和40.8%显示减少100%敦促尿失禁。李李< / > < >虽然背线数据从vibegron第二阶段研究在肠易激综合症,未能达到40.9%的主要终点vibegron IBS-D病人实现至少一个< a href = " https://seekingalpha.com/news/3639299-mid-stage-study-of-urovant-sciences-vibegron-in-irritable-bowel-syndrome-fails-to-meet " target = "平等" > 30%改善腹痛,安慰剂组相比,42.9% < / >。< /李> < / ul >