Vibegron enters European market for overactive bladder

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The decision is supported by findings from the phase 3 EMPOWUR trial and the phase 3 EMPOWUR extension study.

The European Commission has granted marketing authorization to vibegron (Obgemsa) for the symptomatic treatment of adult patients with overactive bladder (OAB).1

Vibegron was approved in the US in December 2020 for the treatment of adult patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Vibegron was approved in the US in December 2020 for the treatment of adult patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency.

The decision 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 delighted with this development, which will allow European patients to benefit from a new therapeutic option for overactive bladder syndrome and further strengthen our expertise of over 40 years in urology. This decision confirms Pierre Fabre Laboratories' commitment to offering patients innovative therapies that provide better management of chronic debilitating diseases," said Eric Ducournau, CEO of Pierre Fabre Laboratories, in the news release.1

This announcement follows a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommending approval of vibegron in this patient population in April 2024. The marketing authorization is applicable across all European Union 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 2020.2 The therapy is also approved in Japan and the Republic of Korea.

The marketing authorization in the EU is supported by findings from the phase 3 EMPOWUR trial (RVT-901-3003; NCT03492281) and the phase 3 EMPOWUR extension study (RVT-901-3004; NCT03583372), which demonstrated the safety and efficacy of vibegron in patients with OAB.

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.3 In total, the EMPOWUR study enrolled 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.

Data showed that 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).

Regarding safety, 1.7% of patients in the vibegron arm discontinued treatment due to adverse events compared with 1.1% for placebo and 3.3% for tolterodine. In both the vibegron and placebo arms, the incidence of hypertension was 1.7%.

Vibegron was further assessed in the phase 3 EMPOWUR extension study, which evaluated the long-term efficacy, tolerability, and safety of vibegron at 52 weeks compared with tolterodine.4

In total, 506 patients were randomized in the study, with 505 patients receiving at least 1 dose of medication and 430 patients completing the study.

Data showed that the improvements in efficacy end points observed during the 12-week primary study were maintained at 52 weeks. A reduction of at least 75% in UUI episodes after 52 weeks of treatment was observed in 61.0% of patients in the vibegron arm vs 54.5% in the tolterodine arm. A 100% reduction in UUI episodes was observed in 40.8% and 34.2% of patients in each arm, respectively.

Overall, the authors concluded that vibegron demonstrated favorable long-term safety, tolerability, and efficacy at 52 weeks in patients with OAB, consistent with that seen in the primary study.

References

1. Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA (vibegron) in overactive bladder. News release. Pierre Fabre. June 28, 2024. Accessed July 1, 2024. https://www.prnewswire.com/news-releases/pierre-fabre-laboratories-announce-granting-of-european-marketing-authorization-for-obgemsa-vibegron-in-overactive-bladder-302185900.html

2. Urovant Sciences announces U.S. FDA Approval of GEMTESA (vibegron) 75 mg tablets for the treatment of patients with overactive bladder (OAB). News release. Sumitomo Pharma. December 2020. Accessed July 1, 2024. https://www.us.sumitomo-pharma.com/newsroom/press-releases/Urovant-Sciences-Announces-US-Commercial-Launch-of-GEMTESA-vibegron-75mg-Tablets-for-Patients-with-Overactive-Bladder/

3. 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

4. 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

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