维贝格龙(vibegron)FDA获批用于膀胱过度活动症的治疗

Vibegron was developed by Sumitomo Pharmaceuticals of Japan and was approved by the FDA for marketing in the United States on December 23, 2024. It became the first and only β3 agonist approved for the treatment of patients with overactive bladder and undergoing treatment for benign prostatic hyperplasia. Verbegaron reduces overactive bladder symptoms by selectively targeting beta-3 adrenergic receptors by relaxing the bladder's detrusor muscle to increase capacity.

Vibegron approved indications

Overactive bladder

‌1. Overactive bladder in adults with symptoms of urge incontinence, urinary urgency and frequency.

2. Overactive bladder accompanied by symptoms of urge incontinence, urinary urgency and frequency in adult men receiving pharmacological treatment for benign prostatic hyperplasia.

About overactive bladder

Overactive bladder is a clinical condition caused by involuntary contractions of the bladder muscles. Symptoms may include: urinary urgency (a sudden and uncontrollable urge to urinate), urge incontinence (involuntary leakage of urine immediately after urination), and urinary frequency (usually eight or more urinations in 24 hours).

About vibegron

Vibegron has been approved in the United States since April 2021 for the treatment of adult bladder symptoms associated with urge incontinence, urinary urgency and frequency. Overactive bladder; and was further approved on December 18, 2024, for the treatment of overactive bladder associated with symptoms of urge incontinence, urinary urgency, and frequency in adult men receiving drug treatment for benign prostatic hyperplasia. The drug works by selectively targeting beta-3 adrenergic receptors, thereby reducing overactive bladder by relaxing the bladder's detrusor muscle to increase bladder capacity.

Precautions for vibegron

1. Urinary retention

It is reported that patients taking vibegron will experience urinary retention. Patients with bladder outlet obstruction and those taking muscarinic antagonist medications to treat overactive bladder may be at increased risk for urinary retention. Monitor patients for signs and symptoms of urinary retention, particularly in patients with bladder outlet obstruction or those taking muscarinic antagonist medications for overactive bladder. Discontinue Vibegroron in patients who develop urinary retention.

2. Angioedema

Angioedema of the face and/or throat has been reported with Vibegroron. Angioedema has been reported to occur hours after the first dose or after multiple doses. Angioedema is associated with swelling of the upper respiratory tract and can be life-threatening. If tongue, hypopharynx, or laryngeal involvement occurs, discontinue Vibegroron immediately and provide appropriate treatment and/or measures necessary to maintain a patent airway.