FDA Approvals Roundup: Gemtesa

RoundupsRoundups | 07 January 2021 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approval
Gemtesa gets the green light for treating adults with overactive bladder
Sumitovant Biopharma’s Gemtesa (vibegron tablet) has been approved as a therapy for adults with overactive bladder (OAB).
The approval was based on efficacy and safety findings from the 12-week double-blind, placebo-controlled phase 3 EMPOWUR study and the double-blind EMPOWUR long-term extension study.
In the phase 3 study, 1,151 adults with OAB were randomized 5:5:4 to receive Gemtesa, placebo, or active control (Detrol). After 12 weeks, patients taking the study drug had statistically significant reductions from baseline in number of daily micturitions (-1.8 vs. -1.3 for placebo patients), urge urinary incontinence (UUI), urgency (need to urinate) episodes (-2.0 vs. -1.4, respectively), and urgency (-2.7 vs. -2.0). Volume voided per micturition increased from baseline by 23 mL and 2 mL, respectively. The phase 3 study also established Gemtesa’s safety. Long-term safety was further demonstrated in an extension study with 505 patients who had completed the 12-week study and were treated for an additional year.
Gemtesa is a beta-3 adrenergic receptor agonist therapy that relaxes muscle in the bladder wall, allowing the bladder to hold more urine and thereby relieving symptoms of UUI, urgency, and urinary frequency in patients with OAB.



© 2022 Regulatory Affairs Professionals Society.

Tags: FDA, US

Discover more of what matters to you

No taxonomy