FDA Accepts Sumitomo’s Vibegron Application for Overactive Bladder in Men with BPH Therapy
Sumitomo Pharma America, Inc. (SMPA) declared a significant development today as the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), intended for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will stand as the pioneer and sole beta-3 agonist for the treatment of men experiencing OAB symptoms while undergoing pharmacological therapy for BPH. The FDA has earmarked a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).
The sNDA is underpinned by the findings from URO-901-3005, a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study. This study assessed the efficacy, safety, and tolerability of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. At Week 12, the study successfully met all co-primary endpoints, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes compared to placebo. Moreover, all secondary endpoints, including reductions in nocturia episodes (awakening to use the bathroom per night) and instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day, were also achieved. Vibegron exhibited good tolerability throughout the study with no new safety signals compared to prior vibegron studies.
“This milestone is pivotal in our mission to introduce innovative treatments for individuals grappling with urological conditions like OAB and BPH,” stated Tsutomu Nakagawa, Ph.D., President, and Chief Executive Officer of SMPA. “We are gratified that the FDA has acknowledged the robustness of the Phase 3 data for vibegron in the URO-901-3005 study within our application. We eagerly anticipate collaborating with the FDA during the review period with the hope of potentially offering a new, safe, and efficacious treatment alternative for men contending with OAB symptoms receiving pharmacological therapy for BPH.”
BPH becomes increasingly prevalent in men as they age, and associated symptoms of OAB can often be misinterpreted as a natural aspect of aging. Nearly half of all men between ages 51 and 60 have BPH, with the prevalence rising to up to 90% in men over age 80. Approximately 46% of patients with bladder outlet obstruction secondary to BPH also experience OAB symptoms.
Vibegron is presently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
About GEMTESA (vibegron)
Vibegron, a once-daily beta-3 adrenergic receptor (β3) agonist, is currently under scrutiny for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia in the United States (U.S.). In the U.S., GEMTESA (vibegron) has been designated for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults since April 2021. GEMTESA operates by selectively targeting β3 adrenergic receptors to alleviate OAB symptoms by relaxing the bladder detrusor muscle to enhance capacity. In China and Europe, vibegron is presently undergoing assessment in a Phase 3 clinical study for the treatment of OAB.
About Overactive Bladder
Overactive bladder (OAB) is a clinical condition characterized by involuntary contraction of the bladder muscle. Symptoms may include urinary urgency (the sudden urge to urinate that is difficult to control), urgency incontinence (unintentional loss of urine immediately after an urgent need to urinate), and frequent urination (usually eight or more times in 24 hours). Approximately 33 million U.S. adults encounter the bothersome symptoms of OAB.
About Benign Prostatic Hyperplasia
Benign prostatic hyperplasia (BPH) is a condition in men characterized by enlargement of the prostate gland. About 60% of men with BPH receive treatment for lower urinary tract symptoms (LUTS). LUTS can be categorized into storage, voiding, and postmicturition symptoms. Over half of men with BPH report storage symptoms, and about a quarter report voiding symptoms, suggesting that many men with a diagnosis of BPH may experience overactive bladder. Many symptomatic men are presumed to have bladder obstruction caused by an enlarged prostate. Approximately half of all men between ages 51 and 60 have BPH, with the prevalence increasing to up to 90% in men over age 80.
Indications and Usage
GEMTESA is a beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
Important Safety Information
Contraindications
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of the product.
Warnings and Precautions
Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction and patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.
Adverse Reactions
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.
For full Prescribing Information, please visit the official website.
About Sumitomo Pharma
Sumitomo Pharma Co., Ltd. is a global pharmaceutical company headquartered in Japan with major operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH). The company is focused on addressing patient needs in oncology, urology, women’s health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products in the U.S., Canada, and Europe, a diverse pipeline of early- to late-stage assets, and in-house advanced technology capabilities, Sumitomo Pharma aims to expedite discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit the official website or follow them on LinkedIn.
