Sumitomo Pharma’s Gemtesa (Vibegron) Secures the US FDA’s Approval to Treat Overactive Bladder (OAB) Symptoms in Men
Shots:
- The US FDA has granted approval to Gemtesa (β3 adrenergic receptor agonist), dosed 75mg, QD, for treating OAB symptoms (urge urinary incontinence, urgency & urinary frequency) in men on benign prostatic hyperplasia (BPH) therapy
- The approval was based on P-III (URO-901-3005) trial assessing Gemtesa vs PBO for the treatment of OAB symptoms in men (n= ~1,100) on BPH therapy, for 24wks.
- Study achieved all co-1EPs at wk.12, showing significant reductions in daily micturition, urgency episodes & urge incontinence episodes per day, with AEs reported in ≥2% of them incl. hypertension & UTIs
Ref: Sumitomo Pharma | Image: Sumitomo Pharma
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