Sumitomo Pharma Announces FDA Acceptance of Supplemental New Drug Application for Vibegron in Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia
- Supplemental New Drug Application (sNDA) submission based on Phase 3 study of vibegron 75mg (GEMTESA) demonstrating statistically significant reductions in daily micturition and urgency episodes
- 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
Reno, Nevada (UroToday.com) -- Sumitomo Pharma America, Inc. (SMPA), announced the U.S. Food and Drug Administration (FDA) has 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).