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Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, has announced the commercial launch of Gemtesa (vibegron) 75 mg tablets, a beta-3 adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.
Urovant Sciences是一家专注于开发和商业化泌尿系统疾病创新疗法的生物制药公司,已宣布商业推出Gemtesa(vibegron)75 mg片剂,一种β-3肾上腺素能受体激动剂,用于治疗患有成人急迫性尿失禁(UUI),尿急和尿频症状的膀胱过度活动症(OAB)。
“Urovant is excited to introduce Gemtesa to the patients and healthcare providers who are in need of a new treatment option to address the bothersome symptoms of OAB,” said Jim Robinson, president and chief executive officer of Urovant. “The launch of Gemtesa is a significant milestone for Urovant, as we are bringing our first product to market.
Urovant总裁兼首席执行官吉姆·罗宾逊(JimRobinson)表示:“Urovant很高兴向需要新治疗方案来解决OAB烦人症状的患者和医疗保健提供者介绍Gemtesa。”。“Gemtesa的推出对于Urovant来说是一个重要的里程碑,因为我们正在将第一款产品推向市场。
It is also an important moment for the entire urology community, as Gemtesa is the first new, oral branded OAB medication to reach the market in nearly a decade.”.
这对整个泌尿外科界来说也是一个重要时刻,因为Gemtesa是近十年来第一种进入市场的新型口服OAB药物。”。
Adults suffering from OAB may experience symptoms of UUI, urgency and urinary frequency, which can have a significant impact on daily activities. Gemtesa is designed to reduce the bothersome symptoms of OAB by relaxing the detrusor bladder muscle so that the bladder can hold more urine. Gemtesa was approved by the FDA in December 2020 and is the first and only beta3 agonist with urgency data and no blood pressure warning in its label.
患有OAB的成年人可能会出现UUI,尿急和尿频的症状,这可能会对日常活动产生重大影响。Gemtesa旨在通过放松逼尿肌膀胱肌肉来减少OAB的烦人症状,从而使膀胱可以容纳更多的尿液。Gemtesa于2020年12月获得FDA批准,是第一种也是唯一一种具有紧急数据且标签上没有血压警告的β3激动剂。
In clinical studies, Gemtesa has been shown to significantly reduce all three key OAB symptoms compared to placebo at Week 12, and there is no known association with cognitive decline for the beta-3 agonist class..
在临床研究中,与安慰剂相比,Gemtesa在第12周时已被证明可显着降低所有三种关键的OAB症状,并且与β-3激动剂类的认知能力下降无关。。
“The availability of Gemtesa is an important step forward in providing patients with a safe, effective option to manage their OAB symptoms,” said Scott A. MacDiarmid, M.D., FRCPSC, Urologist, Alliance Urology Specialists. “Gemtesa will enable us to deliver a patient-centric treatment experience, bringing a new beta-3 agonist to the forefront of the OAB treatment landscape.”.
“Gemtesa的可用性是向前迈出的重要一步,为患者提供了一种安全有效的选择来管理其OAB症状,”医学博士ScottA.MacDiarmid,FRCPSC,泌尿科医生,联盟泌尿科专家说。“Gemtesa将使我们能够提供以患者为中心的治疗体验,将新的β-3激动剂带到OAB治疗领域的前沿。”。
“Many patients continue to suffer from the symptoms of OAB,” said Walt Johnston, executive vice president, commercial, Urovant. “Our robust teams are working diligently to bring Gemtesa to urology specialists, those in a long-term care setting, and other healthcare providers. We look forward to making Gemtesa available nationwide, supported by comprehensive physician and patient education.”.
Urovant商业执行副总裁Walt Johnston说:“许多患者继续患有OAB症状。”。“我们强大的团队正在努力将Gemtesa带给泌尿科专家、长期护理机构的专家和其他医疗保健提供者。我们期待着在全面的医生和患者教育的支持下,在全国范围内提供Gemtesa。”。
Condition: Overactive Bladder
病情:膀胱过度活动
Type: drug
类型:药物