Urovant Sciences Announces Publication of New Review of Efficacy and Safety Data for GEMTESA® (vibegron) 75mg in Patients with Overactive Bladder in Therapeutics and Clinical Risk Management Journal
IRVINE, Calif. and BASEL, Switzerland–(BUSINESS WIRE)– Urovant Sciences, Inc., a wholly owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data for GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and clinical risk management (https://bit.ly/Vibegron). Titled “An evaluation of the efficacy and safety of vibegron in the treatment of overactive bladder,” the article reviews published data from studies conducted over the past three years.
“This new review highlights that across all studies, vibegron was effective, safe, and well tolerated, and is an option for the treatment of patients with overactive bladder, including the elderly,” said the report. lead author Jeffrey Frankel, MD, of Seattle Urology. Research Center. “This product offers a promising alternative to anticholinergics, with clinically meaningful impact for patients.”
“More than a year after the approval of GEMTESA in the United States, these data further underscore the potential clinical benefit of vibegron for patients with overactive bladder,” said Cornelia Haag-Molkenteller, MD, PhD, Executive Chairman and Medical Director of Urovant Sciences.
the Therapeutics and clinical risk management The paper highlights that in the international Phase 3 EMPOWUR trial, treatment with GEMTESA was associated with significant improvements over placebo in efficacy outcomes for voiding frequency, urge urinary incontinence episodes ( UUI), emergency episodes and evacuated volume. The EMPOWUR 40-week extension study evaluated safety in patients receiving GEMTESA for 52 weeks. Treatment with GEMTESA has also been associated with improvements in patient-reported outcomes.
Serious adverse events (AEs) occurred at rates comparable to placebo (1.5% versus 1.1% for vibegron versus placebo, respectively) in EMPOWUR and with the active control (3.3% versus 4.3% for vibegron versus active control, respectively) in the EMPOWUR extension study. In EMPOWUR, the most common treatment-emergent AEs (TEAEs) with a higher incidence for vibegron than for placebo were headache and nasopharyngitis. The incidence of hypertension was similar between the vibegron and placebo treatment groups. In the EMPOWUR extension study, the most common TEAEs with vibegron were hypertension (similar incidence to active control), urinary tract infection, and headache.
A separate, dedicated study in ambulatory blood pressure monitoring showed that vibegron treatment, similar to placebo, was not associated with clinically significant effects on blood pressure or heart rate. In this study, the most common TEAEs with vibegron were hypertension, upper respiratory tract infections, and headache.
According to the article, the improvements in patient-reported outcomes suggest that vibegron achieves both objective measures of clinical efficacy and subjective measures of symptomatic improvement that may be perceived as more meaningful by patients.
The article concludes that further investigation into the actual effectiveness of vibegron is warranted based on the promising efficacy and safety data seen in clinical trials.
About the EMPOWUR trial
The EMPOWUR trial was an international, randomized, double-blind, placebo-controlled, active-comparator, Phase 3 clinical trial evaluating the safety and efficacy of investigational vibegron in men and women with symptoms of overactive bladder, including frequent urination, a sudden urge to urinate, and urge or leak incontinence. A total of 1,518 patients were randomized across 215 study sites to one of three groups for a 12-week treatment period with a four-week safety follow-up period: vibegron 75 mg administered orally once per day ; placebo administered orally once daily; or tolterodine ER 4 mg taken orally once daily.
About the EMPOWUR 40 week extension
The EMPOWUR 40-week extension trial was a Phase 3, multicenter, randomized, double-blind, active-comparator-controlled study to evaluate the long-term safety and efficacy of vibegron in patients with symptoms of overactive bladder. The extension study recruited approximately 500 EMPOWUR graduates. The primary endpoint was safety, measured by the incidence of adverse events. Secondary endpoints were changes from EMPOWUR baseline at week 52 in mean daily voiding, UUI, urgency, and total urinary incontinence.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition that occurs when the bladder muscle contracts involuntarily. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urge incontinence (involuntary loss of urine immediately after an urgent need to urinate), frequent urination (usually eight times or more in 24 hours) and nocturia (waking up more than twice in the night to urinate).1
About 30 million Americans suffer from bothersome symptoms of an overactive bladder, which can have a significant impairment in the patient’s daily activities.1, 2
GEMTESA is a prescription medicine for adults used to treat the following symptoms of a condition called overactive bladder:
- urge urinary incontinence: a strong need to urinate with leaks or pee accidents
- urgency: the need to urinate right away
- frequency: urinating often
It is not known if GEMTESA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Do not take GEMTESA if you are allergic to vibegron or any of the ingredients in GEMTESA.
Before taking GEMTESA, tell your doctor about all your medical conditions, including if you have liver problems; have kidney problems; have difficulty emptying your bladder or your urine stream is weak; taking medications containing digoxin; are pregnant or plan to become pregnant (it is not known if GEMTESA will harm your unborn baby; tell your doctor if you are pregnant or plan to become pregnant); you are breast-feeding or planning to breast-feed (it is not known if GEMTESA passes into your breast milk; talk to your doctor about the best way to feed your baby if you are taking GEMTESA).
Tell your doctor about all the medicines you are taking, including prescription and over-the-counter medications, vitamins and herbal supplements. Know the medications you take. Keep a list to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of GEMTESA?
GEMTESA can cause serious side effects, including the inability to empty your bladder (urinary retention). GEMTESA may increase your risk of not being able to empty your bladder, particularly if you have a bladder outlet obstruction or are taking other medicines for the treatment of overactive bladder. Tell your doctor immediately if you are unable to empty your bladder.
The most common side effects of GEMTESA include headache, urinary tract infections, nasal congestion, sore throat or runny nose, diarrhea, nausea, and upper respiratory tract infections. These are not all the possible side effects of GEMTESA. For more information, consult your doctor or pharmacist.
Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.
Please click here for complete product information for GEMTESA.
About Urovant Sciences
Urovant Sciences is a biopharmaceutical company focused on the development and commercialization of innovative therapies for areas of unmet need, with a particular focus on urology. The company’s flagship product, GEMTESA®(vibegron), is a small molecule beta-3 agonist taken orally once daily (75 mg) for the treatment of adult patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, d urgency and urinary frequency. GEMTESA was approved by the US FDA in December 2020 and launched in the US in April 2021. GEMTESA is also being evaluated for the treatment of overactive bladder in men with benign prostatic hyperplasia. The Company’s second product candidate, URO-902, is a novel gene therapy in development for patients with overactive bladder who have failed oral pharmacological therapy. Urovant Sciences, a wholly owned subsidiary of Sumitovant Biopharma Ltd., intends to bring innovation to patients in need in urology and other areas of unmet need. Learn more about us at www.urovant.com or follow us on Twitter Where LinkedIn.
On Sumitovan Biopharma Ltd.
Sumitovant is a global biopharmaceutical company that leverages data-driven insights to rapidly accelerate the development of potential new therapies for unmet patient conditions. Through our unique portfolio of wholly-owned “Vant” subsidiaries – Urovant, Enzyvant, Spirovant, Altavant – and the use of embedded computing technology platforms to generate business and scientific insights, Sumitovant has supported the development of FDA-approved products and advanced a promising pipeline. from early to late stage investigational assets for other serious conditions. Sumitovant, a wholly owned subsidiary of Sumitomo Dainippon Pharma, is also the majority shareholder of Myovant (NYSE: MYOV). For more information, please visit our website at www.sumitovan.com or follow us on Twitter and LinkedIn.
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top ten listed pharmaceutical companies in Japan, operating globally in major pharmaceutical markets, including Japan, the United States, China and other Asian countries. Sumitomo Dainippon Pharma was formed from the 2005 merger between Dainippon Pharmaceutical Co., Ltd. and Sumitomo Pharmaceuticals Co., Ltd. Today, Sumitomo Dainippon Pharma has over 7,000 employees worldwide. Additional information about Sumitomo Dainippon Pharma can be found on its website at https://www.ds-pharma.com.