San Francisco, CA (UroToday.com) -- Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults.
“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. 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.”
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 U.S. Food and Drug Administration in December 2020 and is the first and only β3 agonist with urgency data and no blood pressure warning in its label. 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.1
“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.”“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.”
- Welk, B., & McArthur, E. (2020). Increased risk of dementia among patients with overactive bladder treated with an anticholinergic medication compared to a beta-3 agonist: a population-based cohort study. BJU International, 126(1), 183–190. https://doi.org/10.1111/bju.15040
Source: WIRE, B., 2021. Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder | Urovant Sciences. [online] Urovant Sciences.
GEMTESA® (vibegron) for the Treatment of Patients with Overactive Bladder FDA Approved - Scott A. MacDiarmid