product approval introduction

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020

female doctor

Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary.  Read more. 

Source: Urology Times, November 20, 2020

Diabetes

autonomic nerves

Over time, diabetes will damage nerves.

Type 2 diabetes is a chronic condition where your body resists the effects of insulin (or does not produce enough insulin) to maintain a normal glucose level in your body.  Type 2 is the most common form of diabetes, with about 95% of all people with diabetes in the USA having this form.  Type 2 diabetes increases your risk and severity for both urinary and fecal incontinence. Continue reading