FDA accepts sNDA for vibegron for OAB symptoms in pharmacologically treated BPH

The FDA has accepted a supplemental new drug application (sNDA) for vibegron (Gemtesa) for the treatment of men with overactive bladder (OAB) symptoms who are receiving pharmacological treatments for benign prostatic hyperplasia (BPH), announced Sumitomo Pharma America (SMPA) the developer of the therapy, in a news release.¹

The sNDA is supported by data from the phase 3 URO-901-3005 trial.

The Prescription Drug User Fee Act target action date is set for quarter 3 of this year. According to the company, if approved, vibegron would mark the first and only beta-3 agonist for the treatment of this patient population.

"This milestone is important in our efforts to bring novel treatments to those living with urological conditions, including OAB and BPH," said Tsutomu Nakagawa, PhD, President and Chief Executive Officer of SMPA, in the news release.¹ "We are pleased the FDA has recognized the strength of the phase 3 data for vibegron in the URO-901-3005 study within our application. We look forward to working with the FDA during the review period in the hopes of potentially providing a new, safe, and effective treatment option for men struggling with OAB symptoms receiving pharmacological therapy for BPH."

The sNDA is supported by data from the phase 3 URO-901-3005 trial (NCT03902080), which reported topline results in September 2023.² 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, data showed that patients who received vibegron experiencing significant reductions in micturition (-2.04; P < .0001) and urgency episodes (-2.88; P < .0001) at baseline compared with patients who received placebo (-1.30 and -1.93, respectively).

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 (IPSS) 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 an average increase in volume voided per micturition 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. Serious adverse events were experienced by 4.3% of patients who received vibegron and 2.9% of patients who received placebo.

In total, the multicenter, randomized, double-blind, parallel-group, fixed-dose URO-901-3005 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 received 75 mg vibegron once daily.³

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.

In the US, vibegron is currently approved for the treatment of adult men with OAB with symptoms of UUI, urgency, and urinary frequency.

References

1. Sumitomo Pharma announces FDA acceptance of supplemental new drug application for vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia. News release. Sumitomo Pharma America. Published online and accessed May 13, 2024. https://www.prnewswire.com/news-releases/sumitomo-pharma-announces-fda-acceptance-of-supplemental-new-drug-application-for-vibegron-in-men-with-overactive-bladder-symptoms-receiving-pharmacological-therapy-for-benign-prostatic-hyperplasia-302143418.html

2. 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. Sumitomo Pharma America. Published online September 11, 2023. Accessed May 13, 2024. https://www.prnewswire.com/news-releases/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-301923356.html

3. Study to evaluate the efficacy, safety and tolerability of vibegron in men with overactive bladder (OAB) symptoms on pharmacological therapy for benign prostatic hyperplasia (BPH). ClinicalTrials.gov. Last updated September 26, 2023. Accessed May 13, 2024. https://clinicaltrials.gov/study/NCT03902080