Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study

Nachrichtenquelle: Business Wire (engl.)
19.11.2020, 14:00  |  88   |   |   

Urovant Sciences (Nasdaq: UROV) today announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks. The data demonstrate that vibegron improved quality of life (QoL) and incontinence efficacy endpoints with good long term tolerability in adult patients with overactive bladder (OAB) and symptoms of urge urinary incontinence (UUI), urgency and urinary frequency.

Vibegron is a once-daily, beta-3 adrenergic agonist under investigation for the treatment of OAB by the U.S. Food and Drug Administration (FDA). In March 2020, the FDA accepted the New Drug Application (NDA) for vibegron in OAB and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020.

In an oral presentation at the virtual International Continence Society (ICS) Annual Meeting, David Staskin, MD, presented results from the 40-week EMPOWUR extension to the 12-week EMPOWUR trial that show 75 mg of vibegron was well tolerated over the total exposure of 52 weeks and demonstrated numerically greater improvements from baseline compared with tolterodine across QoL and responder efficacy endpoints. These results are consistent with the results from the placebo-controlled EMPOWUR phase 3 study, with comparable safety and durable efficacy.

“A large segment of the OAB population suffers in silence because they are embarrassed, afraid, or unaware that there are treatments, including medications, that could address their problems with bladder control. This situation leads to OAB being overlooked and undertreated, and highlights the need for therapeutic options to improve quality of life,” said Dr. Staskin, principal investigator of the EMPOWUR study, leading urologist with St. Elizabeth’s Medical Center, and Associate Professor of Urology at Tufts University School of Medicine, Boston. “The EMPOWUR 40-week extension study demonstrated how vibegron, if approved by the FDA, has the potential to offer a lasting solution for adult patients with OAB to manage urinary frequency and urinary incontinence associated with the urgent need to go to the bathroom.”

At week 52, 61 percent of 143 vibegron-treated patients had a ≥75 percent reduction and 40.8 percent showed a 100 percent reduction in UUI (urge urinary incontinence), a key symptom for OAB patients. In addition, 71.1 percent had ≥50 percent reduction in total incontinence episodes from baseline to week 52. In this same time period, vibegron demonstrated numerically greater improvements from baseline versus tolterodine for all QoL subscale scores as measured by the Overactive Bladder Questionnaire Long Form (OAB-qLF), including coping, concern, sleep, social interaction, health-related QoL and symptom bother. Vibegron 75 mg once daily demonstrated a 40-week safety profile comparable to that of 12-week EMPOWUR study, as well as durable efficacy for QoL and incontinence efficacy endpoints. Adverse events (AEs) occurred in 62.6% (171/273) of vibegron and 54.3% (126/232) of tolterodine patients; 4 (1.5%) vibegron and 8 (3.4%) tolterodine patients discontinued study medication due to an AE.

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Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study Urovant Sciences (Nasdaq: UROV) today announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks. The data demonstrate that vibegron improved quality of life …

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