by Elana Gotkine

Sumitomo Pharma’s Gemtesa (vibegron) has been approved by the U.S. Food and Drug Administration for men with overactive bladder (OAB) symptoms receiving pharmacologic therapy for benign prostatic hyperplasia (BPH).

Gemtesa, a β3 adrenergic receptor agonist, dosed once daily (75 mg), has been approved for men with OAB symptoms, including urinary incontinence, urgency, and urinary frequency, who are receiving pharmacologic treatment for BPH.

The approval was based on results from a 24-week Phase III study of Gemtesa versus placebo in around 1,100 men with OAB symptoms receiving pharmacologic therapy for BPH.

All co-primary end points at week 12 were met, with significant reductions from baseline seen in the average number of micturition episodes per day and in the average number of daily urgency episodes with Gemtesa versus placebo.

In addition, at 12 weeks, there was a reduction in instances of urge urinary incontinence episodes per day. Adverse reactions of hypertension and urinary tract infection exceeding the placebo rate occurred in ≥2 percent of patients treated with Gemtesa.

“The FDA’s expanded approval of Gemtesa is an important milestone for men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need,” Tsutomu Nakagawa, Ph.D., president and chief executive officer of Sumitomo Pharma America Inc., said in a statement.

More information: More Information

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