Sumitomo Pharma America, Inc. announced that the FDA accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®), a beta-3 adrenergic receptor (β3) agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH). If approved, vibegron will be the first and only beta-3 agonist for the treatment of men with OAB symptoms receiving pharmacological therapy for BPH. The FDA has set a target action date in Q3 of FY2024, under the Prescription Drug User Fee Act (PDUFA).
The sNDA is supported by the results from URO-901-3005 a Phase 3 multicenter, randomized, double-blind, parallel-group, fixed-dose study, which evaluated 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. The study met all co-primary endpoints at Week 12, 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 (the sudden urge to urinate that is difficult to control) compared to placebo as well as all secondary endpoints, including reduction of 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. Vibegron was well-tolerated throughout the study and there were no new safety signals compared to prior vibegron studies.
"This milestone is important in our efforts to bring novel treatments to those living with urological conditions including OAB and BPH," said Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA. "We are pleased the FDA has recognized the strength of the Phase 3 data for vibegron in the URO-901-3005 study within our application. We look forward to working with the FDA during the review period in the hopes of potentially providing a new, safe, and effective treatment option for men struggling with OAB symptoms receiving pharmacological therapy for BPH."
BPH is increasingly prevalent in men as they get older and associated symptoms of OAB can often be mistaken as a natural part of aging. Nearly half of all men between ages 51 and 60 have BPH while up to 90% of men over age 80 have BPH.1 Approximately 46% of patients with bladder outlet obstruction secondary to BPH also have OAB.2
Vibegron is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.
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