FDA Accepts Sumitomo Pharma's Application for Vibegron in Men with Overactive Bladder Symptoms with BPH Therapy

Sumitomo Pharma America, Inc. (SMPA) has announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA), a beta-3 adrenergic receptor agonist, for treating men with overactive bladder (OAB) symptoms who are undergoing pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will become the first beta-3 agonist specifically indicated for this patient group. The FDA has scheduled the target action date for the third quarter of fiscal year 2024 under the Prescription Drug User Fee Act (PDUFA).

The sNDA is backed by data from a Phase 3 study (URO-901-3005), which was a multicenter, randomized, double-blind trial involving about 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study assessed the efficacy, safety, and tolerability of vibegron compared to a placebo over 24 weeks. Results at Week 12 showed statistically significant reductions in the average number of urination episodes per day and daily urgency episodes in the vibegron group compared to the placebo group. Secondary endpoints, including reductions in nocturia episodes (nighttime awakenings to urinate) and urge urinary incontinence episodes, were also achieved. Vibegron was well-tolerated with no new safety concerns emerging during the study.

"This milestone is critical as we seek to provide innovative treatments for urological conditions such as OAB and BPH," stated Tsutomu Nakagawa, President and CEO of SMPA. "We are pleased that the FDA has acknowledged the robust Phase 3 data in our sNDA. We look forward to collaborating with the FDA throughout the review process and hope to offer a new, safe, and effective treatment for men dealing with OAB symptoms in conjunction with BPH."

BPH is a common condition affecting older men. Symptoms of OAB are often mistaken for normal aging. Statistics show that nearly half of men aged 51-60 have BPH, and this figure rises to 90% for men over 80. About 46% of patients with bladder outlet obstruction due to BPH also experience OAB. Vibegron is already approved for treating OAB symptoms in adults, including urge urinary incontinence, urgency, and urinary frequency.

Vibegron, marketed as GEMTESA, is a once-daily beta-3 adrenergic receptor agonist. It is currently under investigation for treating men with OAB symptoms receiving pharmacological therapy for BPH in the United States. In the U.S., GEMTESA has been approved since April 2021 for treating OAB symptoms in adults. It works by targeting β3 adrenergic receptors to relax the bladder detrusor muscle, thereby reducing OAB symptoms and increasing bladder capacity. Phase 3 clinical studies for vibegron are also ongoing in China and Europe for treating OAB.

Overactive bladder (OAB) is a condition characterized by involuntary bladder muscle contractions, leading to symptoms such as urinary urgency, urgency incontinence, and frequent urination. Approximately 33 million U.S. adults suffer from OAB’s bothersome symptoms.

Benign prostatic hyperplasia (BPH) is a condition where the prostate gland is enlarged, affecting many men as they age. About 60% of men with BPH are treated for lower urinary tract symptoms (LUTS), which can include storage, voiding, and post-micturition symptoms. Over half of men with BPH report storage symptoms, while a quarter report voiding symptoms, indicating a significant overlap with OAB symptoms. Nearly half of men aged 51-60 and up to 90% of men over 80 live with BPH.