Sumitomo Pharma America Announces FDA Approval of GEMTESA for Men with Overactive Bladder Due to BPH

Sumitomo Pharma America, Inc. (SMPA) has announced that the U.S. Food and Drug Administration (FDA) has granted approval for GEMTESA® (vibegron), a beta-3 adrenergic receptor agonist, to be used as a treatment option for men experiencing overactive bladder (OAB) symptoms while receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This milestone establishes GEMTESA as the first and only beta-3 agonist authorized to address these symptoms in such a patient demographic, and the medication is now accessible for prescription in the United States.

The prevalence of BPH increases as men age, and it is often accompanied by OAB symptoms, which might be misinterpreted as typical signs of aging. In the U.S., approximately 14 million men are affected by BPH, and a significant proportion, up to 75%, also exhibit clinical symptoms indicative of OAB. Despite the overlap, OAB symptoms frequently go undiagnosed in men, with estimates suggesting that around 80% of OAB cases remain unidentified.

Dr. Tsutomu Nakagawa, President and CEO of SMPA, highlighted the significance of this FDA approval, noting that millions of men grappling with the dual challenge of OAB and BPH have had limited treatment options. He described this regulatory milestone as crucial for those with unresolved OAB symptoms and emphasized the company's commitment to addressing unmet medical needs.

The FDA's decision to approve GEMTESA is supported by data from a Phase 3 clinical trial named URO-901-3005. The study involved approximately 1,100 men who were concurrently receiving treatment for BPH. Over a period of 24 weeks, GEMTESA demonstrated notable improvements compared to placebo, meeting all primary endpoints by the 12th week. The trial results showed significant reductions in daily micturition episodes and urgency episodes, while an additional endpoint revealed a decrease in the frequency of urge urinary incontinence episodes. Adverse side effects reported in at least 2% of the participants taking GEMTESA, which were more common than with placebo, included hypertension and urinary tract infections.

Yumi Sato, Chief Development Officer at SMPA, expressed optimism about GEMTESA's potential to offer improved management of OAB symptoms for patients also undergoing BPH treatment. With the introduction of this pioneering beta-3 agonist, SMPA aims to provide men experiencing these conditions with a more manageable lifestyle, reducing the interruptions caused by OAB symptoms.

GEMTESA is approved for treating adult OAB symptoms, including urge urinary incontinence, urgency, and frequent urination, and is now specified for men whose OAB is associated with BPH treatment. Given the complexity and overlap of BPH and OAB symptoms, such a therapeutic option is poised to significantly impact patient care.

Sumitomo Pharma Co., Ltd., headquartered in Japan, operates globally with subsidiaries like Sumitomo Pharma America, Inc. in the U.S. The company is dedicated to advancing healthcare solutions across various therapeutic areas, including oncology, urology, women's health, and more. With a diverse portfolio and a robust development pipeline, Sumitomo Pharma aims to expedite the delivery of innovative treatments to meet patient needs worldwide.