Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., announced new analyses from the Phase 3 EMPOWER Extension Study of GEMTESA, presented Sunday at the 2022 annual meeting of the American Urological Association (AUA2022). The meeting is being held in New Orleans from May 13-16, 2022.
The additional analyses of data on our overactive bladder therapy, GEMTESA, further confirm this drug’s potential utility and durability in this patient population,” said Sef Kurstjens, MD, Ph.D., Executive Vice President and Chief Medical Officer of Urovant Sciences. This is an additional demonstration of Urovant’s commitment to providing effective therapies for patients with urologic conditions.
Two podium presentations at AUA2022 on May 15 featured new analyses of data from the EMPOWER 40-week extension trial of GEMTESA (vibegron) 75 mg. This was a Phase 3, randomized, double-blind, active-comparator controlled, parallel-group multicenter study to evaluate long-term safety and efficacy in patients with symptoms of OAB. GEMTESA is approved by the U.S. Food and Drug Administration for the treatment of OAB symptoms of UUI, urgency, and urinary frequency in adults.
The first podium presentation, PD38-11, presented at 8:40-8:50 a.m. by Jeffrey Frankel, MD, Medical Director, Seattle Urology Research Center, Seattle, Washington, is titled, “Long-Term Efficacy and Safety of Vibegron for Overactive Bladder in Patients ≥65 Years Old: Analysis from the EMPOWER Extension Trial.” In a subgroup analysis of adults, 65 years old or above with overactive bladder, treatment with GEMTESA was safe and well-tolerated. Treatment with GEMTESA was associated with sustained reductions from baseline in average daily micturition, UUI episodes, and urgency episodes. These results were consistent with the overall EMPOWER Extension Study population.
The second podium presentation, PD38-12, presented at 8:50-9:00 a.m. by David Staskin, MD, Associate Professor of Urology, Tufts University School of Medicine, is titled, “Long-Term Patient-Reported Outcomes of Vibegron for Overactive Bladder: Analyses from the EMPOWER Extension Trial. This analysis of data from the EMPOWER Extension Trial supports that patient-perceived meaningful improvements in the OAB questionnaire (OAB-q) and Patient Global Impression (PGI) scores were consistent with GEMTESA’s improvements in OAB symptoms and favorable safety and tolerability profile during the 52-week treatment period.
