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
MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today 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).
- MARLBOROUGH, Mass., May 13, 2024 /PRNewswire/ -- Sumitomo Pharma America, Inc. (SMPA), announced today 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).
- "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.