FDA approves vibegron for OAB symptoms in pharmacologically treated BPH

The FDA has approved vibegron (Gemtesa) for the treatment of patients with overactive bladder (OAB) symptoms who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH), Sumitomo Pharma America (SMPA) announced in a news release.¹

The COURAGE trial met its 2 co-primary end points.

According to the company, this approval marks the first and only beta-3 (β₃) agonist approved for this indication. Vibegron was previously approved in the US for the treatment of adult patients with OAB with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency.

"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," said Yumi Sato, Chief Development Officer at SMPA, in the news release.¹ "With this FDA approval and launch of the first β₃ agonist for men with OAB symptoms being pharmacologically treated for BPH, we have the potential to give men living with this disease a life with fewer interruptions due to their OAB symptoms."

Data on vibegron

The approval of vibegron is supported by data from the phase 3 COURAGE trial ( NCT03902080; URO-901-3005), which were presented at the 2024 American Urological Association Annual Meeting and concurrently published in the Journal of Urology.^2,3

Overall, the study met its 2 co-primary end points by demonstrating statistically significant reductions in the average number of micturition episodes and urgency episodes per day from baseline to 12 weeks with vibegron vs placebo, as well as all secondary end points, including reductions in the average number of nocturia episodes and instances of UUI episodes.

At 12 weeks, patients who received vibegron experienced significant reductions in the average number of micturition (-2.04; SE, 0.109; P < .0001) episodes per day and daily urgency episodes (-2.88; SE, 0.164; P < .0001) from baseline compared with patients who received placebo (-1.30 and -1.93, respectively). These improvements were noted in week 2 and observed through week 24 of the trial.

Additionally, all secondary end points in the study were met at 12-week follow-up. Patients who received vibegron experienced significant reductions in the average number of nocturia episodes per night compared with patients who received placebo (-0.88 and -0.66, respectively; P = .0015), as well as in the average number of UUI episodes per day (-2.19 and -1.39, respectively; P = .0034).

The vibegron cohort also demonstrated a greater reduction in International Prostate Symptom Storage scores compared with the placebo group (-3.0 and -2.1, respectively; P < .0001) at 12-week follow-up. Further, men who received vibegron experienced a significant increase in the volume voided per micturition, with a least squares mean increase of 25.63 mL compared with 10.56 mL among patients who received placebo (P < .0001).

Overall, treatment with vibegron was well-tolerated, and safety signals were consistent with previously reported studies. Adverse events (AEs) were reported in 45% of patients in the vibegron arm and 39% of patients in the placebo arm. Serious AEs were experienced by 4.3% of patients who received vibegron and 2.9% of patients who received placebo. AEs reported by 2% or more of patients included hypertension (9.0% vibegron vs 8.3% placebo), COVID-19 (4.0% vs 3.1%), urinary tract infection (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%).

Regarding quality-of-life measures, patients in the vibegron arm demonstrated significant improvements from baseline to week 12 and 24 in the OAB questionnaire long-form vs those in the placebo arm (P < .0001).

In total, the multicenter, randomized, double-blind, parallel-group, fixed-dose COURAGE study enrolled 1105 men with OAB symptoms who were receiving therapy with either an alpha blocker monotherapy or an alpha blocker plus 5-alpha reductase inhibitor for BPH. Patients in the study were randomly assigned 1:1 to receive 75 mg vibegron once daily or to placebo for 24 weeks.

The co-primary end points for the study were the change in the average number of micturition episodes and urgency episodes per day from baseline to 12 weeks with vibegron vs placebo. Secondary end points of the study were changes in the average number of nocturia episodes, UUI episodes, IPSS scores, and the average volume voided per micturition.

References

1. Sumitomo Pharma America announces U.S. FDA approval of GEMTESA (vibegron) for men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. News release. Sumitomo Pharma America. Published online and accessed December 23, 2024. https://news.us.sumitomo-pharma.com/2024-12-23-Sumitomo-Pharma-America-Announces-U-S-FDA-Approval-of-GEMTESA-R-vibegron-for-Men-with-Overactive-Bladder-Symptoms-Receiving-Pharmacological-Therapy-for-Benign-Prostatic-Hyperplasia

2. Sumitomo Pharma presents urology and oncology data at AUA 2024.Annual Meeting. News release. Sumitomo Pharma America. May 7, 2024. Accessed December 23, 2024. https://news.us.sumitomo-pharma.com/2024-05-07-Sumitomo-Pharma-Presents-Urology-and-Oncology-Data-at-AUA-2024-Annual-Meeting

3. Staskin D, Owens-Grillo J, Thomas E, Rovner E, Cline K, Mujais S. Efficacy and safety of vibegron for persistent symptoms of overactive bladder in men being pharmacologically treated for benign prostatic hyperplasia: Results from the phase 3 randomized controlled COURAGE trial. J Urol. 2024;212(2):256-266. doi:10.1097/JU.0000000000003999