EMA recommends approval of vibegron for OAB
Following the positive recommendation, the European Commission will now review the application for vibegron for potential approval in the OAB setting in all EU member states, as well as in Iceland, Liechtenstein, and Norway.
The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of vibegron (Obgemsa) for the symptomatic treatment of adult patients with overactive bladder (OAB).
The recommendation is based on data from the phase 3 EMPOWUR trial and its extension study, as well as the phase 1 URO-901-1001 trial.
The recommendation was announced in a news release from Pierre Fabre Laboratories,1 who holds the exclusive rights to register and commercialize vibegron in the European Economic Area.
"We are very pleased to have received this positive opinion from the CHMP for OBGEMSA. If approved, this innovative therapeutic solution has the potential to help patients suffering from overactive bladder, a condition that is very debilitating in daily life. We have been working in the field of urology for more than 40 years, and OBGEMSA is proof of our determination to continue our development in this area,” said Eric Ducournau, CEO of Pierre Fabre Laboratories, in the news release.1
Following the CHMP’s positive recommendation, the European Commission will now review the application for vibegron for potential approval in the OAB setting in all EU member states, as well as in Iceland, Liechtenstein, and Norway. Vibegron (Gemtesa) is currently approved in the US for the treatment of adult patients with OAB with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency based on an FDA decision in December 2020. The therapy is also approved in Japan and the Republic of Korea.
The positive opinion from the CHMP is based on data from the phase 3 EMPOWUR trial (RVT-901-3003; NCT03492281) and its extension study (RVT-901-3004; NCT03583372), as well as the phase 1 URO-901-1001 trial.
The primary phase 3 EMPOWUR study evaluated the efficacy, tolerability, and safety of 75 mg daily vibegron at 12 weeks compared with placebo and tolterodine (Detrol) in patients with OAB.2 The extension study assessed the long-term efficacy, tolerability, and safety of vibegron at 52 weeks compared with tolterodine.
In total, the primary EMPOWUR study included 1518 patients who were randomly assigned 5:5:4 to 75 mg vibegron, placebo, or 4 mg tolterodine. Of those, 90.4% of patients completed the trial.
At 12 weeks, microuritions decreased by an adjusted average of 1.8 episodes per day among those who received vibegron compared with 1.3 among those who received placebo (P < .001) and 1.6 among those who received tolterodine. Among patients that were incontinent, UUI episodes decreased by an adjusted average of 2.0 episodes per day in the vibegron arm, compared with 1.4 in the placebo arm (P < .0001) and 1.8 in the tolterodine arm.
Vibegron also demonstrated statistically significant improvements in key secondary end points of volume per microurition, the number of urgency episodes, and the proportion of incontinent patients who achieved a 75% or greater reduction in UUI episodes (all P < .01).
The EMPOWUR extension study demonstrated results consistent with those of the 12-week primary study, showing favorable long-term safety, tolerability, and efficacy of vibegron at 52 weeks among those with OAB.3
The CHMP decision was also supported by findings from the phase 1 URO-901-1001 trial, which evaluated the effect of vibegron on ambulatory blood pressure (BP) and heart rate (HR).4
In total, the study randomly assigned 214 patients with OAB, of which 96 received vibegron and 101 received placebo. Overall, the study showed no statistically significant effects of vibegron on BP or HR.
Data showed that least squares mean difference between vibegron and placebo in change from baseline to day 28 in mean daytime ambulatory systolic BP was 0.8 mmHG. The least squares mean difference in change from baseline in mean daytime 24-hour ambulatory diastolic BP was 0.0 mmHg, and the least squares mean difference in change from baseline in HR was 0.9 bpm. No significant differences were observed between treatments regarding the secondary end points of change from baseline in mean 24-hour systolic BP (least squares mean difference, 0.6 mmHg), diastolic BP (-0.2 mmHg), or HR (1.0 bpm).
References
1. Pierre Fabre Laboratories receive positive CHMP opinion for OBGEMSA (vibegron) in overactive bladder syndrome. News release. Pierre Fabre. April 26, 2024. Accessed April 29, 2024. https://www.prnewswire.com/news-releases/pierre-fabre-laboratories-receive-positive-chmp-opinion-for-obgemsavibegron-in-overactive-bladder-syndrome-302128768.html
2. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd Jr PN. International phase III, randomized, double-blind, placebo and active controlled study to evaluate the safety and efficacy of vibegron in patients with symptoms of overactive bladder: EMPOWUR. J Urol. 2020;204(2):316-324.doi:10.1097/JU.0000000000000807
3. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd Jr PN. Once-daily vibegron 75 mg for overactive bladder: long-term safety and efficacy from a double-blind extension study of the international phase 3 trial (EMPOWUR). J Urol. 2021;205(5):1421-1429. doi:10.1097/JU.0000000000001574
4. Weber MA, Haag-Molkenteller C, King J, Walker A, Mudd Jr PN, White WB. Effects of vibegron on ambulatory blood pressure in patients with overactive bladder: results from a double-blind, placebo-controlled trial. Blood Press Monit. 2022;27(2):128-134.doi:10.1097/MBP.0000000000000572
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