Sumitomo Pharma America Announces FDA Approval of GEMTESA for Overactive Bladder

Sumitomo Pharma America, announced today that the U.S. Food and Drug Administration (FDA) has approved GEMTESA (vibegron), a beta-3 (β₃) adrenergic receptor agonist, dosed once-daily (75 mg), for the treatment of men with overactive bladder (OAB) symptoms, such as urge urinary incontinence, urgency, and urinary frequency, who are receiving pharmacological therapy for benign prostatic hyperplasia (BPH). This approval marks GEMTESA as the first and only β₃ agonist approved to treat patients living with OAB and being treated for BPH. It is currently available for prescription in the U.S.

BPH is increasingly prevalent in men as they get older, and OAB symptoms, which could be associated with BPH, can often be mistaken as a natural part of aging. There are about 14 million men in the U.S. living with BPH, and up to 75% of them have clinical symptoms of OAB.^1,2 OAB symptoms may go unnoticed in men, especially if they have BPH.³ In fact, ~80% of OAB cases in men may go undiagnosed.

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“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.” said Tsutomu Nakagawa, Ph.D., President and Chief Executive Officer of SMPA. “The FDA’s expanded approval of GEMTESA is an important milestone for the men with unresolved symptoms of OAB while being treated for BPH, which underscores our urgency to deliver for those affected by conditions with unmet need.”

The FDA’s approval of GEMTESA is based on results from URO-901-3005, a Phase 3 study of vibegron versus placebo over 24 weeks in approximately 1,100 men with OAB symptoms receiving pharmacological therapy for BPH. The study met all co-primary endpoints at Week 12, demonstrating statistically significant reductions from baseline in the average number of micturition (urination) episodes per day and in the average number of daily urgency episodes (sudden urge to urinate that is difficult to control) compared to placebo. An additional endpoint showed a reduction in instances of urge urinary incontinence episodes (unintentional loss of urine immediately after an urgent need to urinate) per day at 12 weeks.  Adverse reactions, exceeding placebo rate, reported in ≥2% of patients treated with GEMTESA were hypertension and urinary tract infection.

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Please see Important Safety Information below.

“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 gain better control of their symptoms,” said Yumi Sato, Chief Development Officer, SMPA. “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.”

GEMTESA (vibegron) is currently approved for OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults, and is now available for prescription in the U.S. for the treatment of men with OAB being pharmacologically treated for BPH.

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IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
GEMTESA is contraindicated in patients with known hypersensitivity to vibegron or any components of GEMTESA. Hypersensitivity reactions, such as angioedema, have occurred.

WARNINGS AND PRECAUTIONS
Urinary Retention
Urinary retention has been reported in patients taking GEMTESA. The risk of urinary retention may be increased in patients with bladder outlet obstruction and also in patients taking muscarinic antagonist medications for the treatment of OAB. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or patients taking muscarinic antagonist medications for the treatment of OAB. Discontinue GEMTESA in patients who develop urinary retention.

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Angioedema
Angioedema of the face and/or larynx has been reported with GEMTESA. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema, associated with upper airway swelling, may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, immediately discontinue GEMTESA and provide appropriate therapy and/or measures necessary to ensure a patent airway.

ADVERSE REACTIONS
Most common adverse reactions (≥2%) reported with GEMTESA were headache, urinary tract infection, nasopharyngitis, diarrhea, nausea, and upper respiratory tract infection.

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INDICATIONS AND USAGE
GEMTESA® is a beta-3 adrenergic agonist indicated for the treatment of:

overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adult males on pharmacological therapy for benign prostatic hyperplasia (BPH).

overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.

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Source – prnewswire