Posted by Michael Wonder on 14 May 2024
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
13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically significant reductions in daily micturition and urgency episodes.
Sumitomo Pharma announced today the US FDA has accepted its supplemental new drug application for vibegron (Gemtesa), a beta 3 adrenergic receptor agonist, dosed once daily (75 mg), for the treatment of men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia.
