FDA Approves Gemtesa for Men With BPH and Overactive Bladder

On Thursday, January 2, 2025, the U.S. Food and Drug Administration (FDA) announced the approval of Gemtesa (vibegron) for men experiencing symptoms of overactive bladder (OAB) while undergoing pharmacological treatment for benign prostatic hyperplasia (BPH). This approval marks a significant advancement in the management of such conditions, according to a statement released by Sumitomo Pharma.

Gemtesa is a β3 adrenergic receptor agonist, administered as a 75 mg dose once daily. It has been approved specifically for men with OAB symptoms—including urinary incontinence, urgency, and increased urinary frequency—who are simultaneously receiving treatment for BPH. The FDA's decision was informed by data from a robust 24-week phase 3 clinical trial, which compared the effects of Gemtesa to a placebo in approximately 1,100 men with OAB symptoms under pharmacologic therapy for BPH.

The trial successfully met all coprimary endpoints by week 12, demonstrating significant improvements in patients taking Gemtesa compared to those on the placebo. Key results included a noticeable reduction in the average number of daily micturition episodes and a decrease in daily urgency episodes. Furthermore, by the 12-week mark, a reduction was also observed in the frequency of urge urinary incontinence episodes among patients using Gemtesa.

However, the study also identified some adverse reactions associated with Gemtesa use. Notably, hypertension and urinary tract infections were reported at rates exceeding those in the placebo group, occurring in at least 2 percent of patients treated with Gemtesa.

Tsutomu Nakagawa, Ph.D., president and CEO of Sumitomo Pharma America Inc., emphasized the significance of FDA’s expanded approval. He remarked that this development represents a crucial milestone for men who continue to experience OAB symptoms despite being treated for BPH. Nakagawa highlighted the importance of addressing conditions with unmet medical needs, underscoring the company's commitment to improving the quality of life for affected individuals.

Sumitomo Pharma has been granted the approval for Gemtesa by the FDA, reinforcing the company's role in advancing therapeutic options for complex conditions like OAB and BPH. The approval offers hope to many who have struggled to manage their symptoms with existing treatments.

In conclusion, the FDA's approval of Gemtesa provides a new treatment avenue for men grappling with the dual challenges of OAB and BPH. The positive outcomes from the clinical trial underscore Gemtesa's potential to enhance patient care by alleviating persistent symptoms, thereby improving daily life for many men. As Sumitomo Pharma continues its efforts in this domain, the availability of Gemtesa is poised to make a meaningful impact in the therapeutic landscape for these prevalent conditions.