FDA Approves GEMTESA For Overactive Bladder In Men With Benign Prostatic Hyperplasia

Sumitomo Pharma America, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved GEMTESA® (vibegron) for treating men with overactive bladder (OAB) symptoms associated with benign prostatic hyperplasia (BPH). This once-daily, 75 mg beta-3 (β3) adrenergic receptor agonist is the first and only medication in its class approved for this specific group. GEMTESA is now available for prescription in the U.S., offering a new solution for men struggling with symptoms such as frequent urination, urgency, and urge urinary incontinence while undergoing treatment for BPH.

“The clinical data on once-daily vibegron demonstrated clear improvements in key OAB symptoms in patients also receiving pharmacological therapy for BPH, showcasing the potential of GEMTESA to offer patients a way to better control their symptoms. With this FDA approval and launch of the first β3 agonist for men with OAB symptoms being pharmacologically treated for BPH, we have the potential to give men living with this disease a life with fewer interruptions due to their OAB symptoms,” said Yumi Sato, Chief Development Officer, SMPA

BPH is a common condition that becomes increasingly prevalent as men age, with an estimated 14 million men in the U.S. living with it. Many of these men, up to 75%, experience OAB symptoms, which are often mistaken as a natural part of ageing and therefore go unnoticed or undiagnosed. Studies suggest that approximately 80% of OAB cases in men may remain undetected, leaving a significant portion of the population untreated. With this approval, GEMTESA provides a much-needed treatment option for men with OAB symptoms that impact their daily lives.

Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA, said in a statement, “Millions of patients suffer from OAB along with existing BPH. OAB is a urological condition that has limited treatment options to address their symptoms and impact on their social life. The FDA’s expanded approval of GEMTESA is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, underscoring our urgency to deliver for those affected by conditions with unmet need."

The results of the URO-901-3005 Phase 3 clinical trial support the FDA's decision, which involved around 1,100 men over 24 weeks. The study demonstrated that GEMTESA significantly reduced daily episodes of urination, urgency, and urge urinary incontinence compared to placebo at 12 weeks. The medication was generally well tolerated, with the most commonly reported side effects being hypertension and urinary tract infections, each occurring in more than 2% of patients. With this expanded indication, GEMTESA is poised to address a critical gap in OAB treatment for men receiving pharmacological therapy for BPH.