FDA

Gemtesa OK’d for men with OAB symptoms receiving BPH therapy

January 1, 2025

Brand name: Gemtesa

Generic name: vibegron

Manufacturer: Sumitomo Pharma

Approval date: December 23, 2024

FDA approved Gemtesa (vibegron), a beta-3 adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH).

Efficacy

Approval was based on results from URO-901-3005 (NCT03902080), a phase 3 study of vibegron vs. placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at week 12, showing statistically significant reductions from baseline in average number of urination episodes per day and average number of daily urgency episodes compared with placebo. Gemtesa recipients also experienced a reduction in instances of urge urinary incontinence episodes per day at 12 weeks.

Safety

Adverse reactions exceeding placebo (≥2% of patients treated with Gemtesa) were headache, UTI, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

Recommended dose

The recommended dosage of Gemtesa is 75 mg PO once daily.

Sources:

Sumitomo Pharma. (2024, December 23). Sumitomo Pharma America Announces U.S. FDA Approval of GEMTESA (vibegron) for Men with Overactive Bladder Symptoms Receiving Pharmacological Therapy for Benign Prostatic Hyperplasia. [Press release]. https://www.sumitomo-pharma.com/news/assets/pdf/ene20241224.pdf

Sumitomo Pharma: Gemtesa (vibegron). [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213006s011lbl.pdf