FDA Approves Vibegron for Men With Overactive Bladder Symptoms Receiving Therapy for Benign Prostatic Hyperplasia

Today, the FDA granted regulatory approval to vibegron (Gemtesa; Sumitomo Pharma America), a beta-3 (β₃) andrenergic receptor agonist dosed once daily, for the treatment of men with overactive bladder (OAB) symptoms who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH), according to a news release from Sumitomo Pharma America (SMPA).¹

"The clinical data on once-daily vibegron demonstrated clear improvements in key OAB symptoms in patients also receiving pharmacological therapy for BPH, showcasing the potential of Gemtesa to offer patients a way to gain better control of their symptoms," Yumi Sat, chief development officer of SMPA, said in the news release. “We have the potential to give men living with this disease a life with fewer interruptions due to their OAB symptoms."¹

Image Credit: © Tom | stock.adobe.com

According to the news release, the approval makes vibegron the first and only β3 agonist approved to treat patients living with OAB and being treated with BPH and is currently available for prescription in the United States. Often mistaken as a natural aspect of aging, OAB symptoms can be associated with BPH, an increasingly prevalent condition in men as they age. Millions of men in the United States live with BPH, with up to 75% of them having clinical symptoms of OAB. Unfortunately, around 80% of OAB cases in men can go undiagnosed.^1,2

The regulatory action is based on results of URO-901-3005, a phase 3 trial analyzing vibegron versus placebo over 24 weeks in around 1100 men with OAB symptoms receiving pharmacological therapy for BPH. In results announced in 2023, vibegron met both co-primary end points, including change from baseline in the average number of urination episodes per day and change from baseline in the average number of urgency episodes per day.^1,3

Another end point indicated a reduction in instances of urgent urinary incontinence episodes (an unintentional loss of urine immediately after an urgent need to urinate) per day at 12 weeks. Adverse reactions included urinary tract infection and hypertension, with a 4.3% frequency of serious adverse events—a similar rate to the placebo arm (2.9%), according to the investigators.^1,3

"Millions of patients suffer from OAB along with existing BPH. OAB is a urological condition that has limited treatment options to address their symptoms and impact on their social life,” Tsutomu Nakagawa, PhD, president and chief executive officer of SMPA, said in the news release. “The FDA's expanded approval of [vibegron] is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH.”¹

REFERENCES

1. Sumitomo Pharma America. Sumitomo Pharma America announces US FDA approval of Gemtesa (vibegron) for men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. PR Newswire. News Release. Released December 23, 2024. Accessed December 23, 2024. https://www.prnewswire.com/news-releases/sumitomo-pharma-america-announces-us-fda-approval-of-gemtesa-vibegron-for-men-with-overactive-bladder-symptoms-receiving-pharmacological-therapy-for-benign-prostatic-hyperplasia-302338114.html

2. Dmochowski RR, Gomelsky A. Overactive bladder in males. Ther Adv Urol. 2009;1(4):209-221. doi:10.1177/1756287209350383

3. Sumitomo Pharma America. Sumitomo Pharma announces positive topline results from phase 3 clinical studies evaluating vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. News Release. Released September 11, 2023. Accessed December 23, 2024. https://news.us.sumitomo-pharma.com/2023-09-11-Sumitomo-Pharma-Announces-Positive-Topline-Results-from-Phase-3-Clinical-Studies-Evaluating-Vibegron-in-Men-with-Overactive-Bladder-Symptoms-Receiving-Pharmacological-Therapy-for-Benign-Prostatic-Hyperplasia