Sumitomo Pharma America announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for vibegron (GEMTESA®) for the treatment of men with overactive bladder (OAB) symptoms who are also receiving pharmacological therapy for benign prostatic hyperplasia (BPH). Vibegron, a beta-3 adrenergic receptor (β3) agonist, is administered once daily at a 75 mg dose. 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 data from the Phase 3 URO-901-3005 study, a multicenter, randomized, double-blind, parallel-group, fixed-dose trial. This study 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 trial met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition episodes per day and in the average number of daily urgency episodes compared to placebo. Secondary endpoints, including reduction of nocturia episodes and urge urinary incontinence episodes per day, were also met. Vibegron was well-tolerated, with no new safety signals identified compared to prior studies.
Clinical Significance
Tsutomu Nakagawa, Ph.D, President and Chief Executive Officer of SMPA, stated, "This milestone is important in our efforts to bring novel treatments to those living with urological conditions including OAB and BPH. 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."
Disease Burden and Current Treatment Landscape
BPH is increasingly prevalent with age, affecting nearly half of men between 51 and 60 years old and up to 90% of men over 80. Symptoms of OAB associated with BPH are often mistaken as a natural part of aging. Approximately 46% of patients with bladder outlet obstruction secondary to BPH also have OAB.
Vibegron is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults. If approved for this new indication, vibegron would be the first and only beta-3 agonist available for men with OAB symptoms undergoing pharmacological treatment for BPH.
Mechanism of Action
Vibegron selectively targets β3 adrenergic receptors, relaxing the bladder detrusor muscle to increase bladder capacity and reduce OAB symptoms.
Safety Information
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any of its components. Urinary retention has been reported in patients taking GEMTESA, particularly in those with bladder outlet obstruction or those also taking muscarinic antagonist medications for OAB. Common adverse reactions (≥2%) reported with GEMTESA include headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.
