Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study
Extension study demonstrates favorable results in long term treatment of overactive bladder with vibegron, including improvements in incontinence efficacy, quality of life endpoints and with good tolerability
Long term EMPOWUR extension study data featured in an oral presentation at the virtual
Meta-analysis on increased risk of incident dementia following use of anticholinergics will also be presented at ICS
Vibegron is a once-daily, beta-3 adrenergic agonist under investigation for the treatment of OAB by the
In an oral presentation at the virtual
“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
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.
Examining the Risk of Cognitive Effects Associated with Anticholinergic Agents
Anticholinergic medications are currently the most frequently prescribed pharmaceutical treatment for OAB. They exert their effects by blocking the action of the neurotransmitter acetylcholine and are prescribed to treat a wide range of medical conditions.
“The findings from our systematic literature review and meta-analysis shine a light on what data and anecdotal evidence has demonstrated for many practicing physicians: ongoing use of anticholinergics to treat OAB comes with an increased risk,” said
Sumitovant is a global biopharmaceutical company with offices in
About Sumitomo Dainippon Pharma Co., Ltd.
Sumitomo Dainippon Pharma is among the top-ten listed pharmaceutical companies in
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations and can be identified by words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “strive,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements regarding Urovant’s plans to advance the clinical development of vibegron in patients with OAB, including related to the status of potential FDA approval. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to, risks associated with: the success, cost, and timing of Urovant’s development activities, including the timing of the initiation and completion of clinical trials and the timing of expected regulatory filings; the FDA’s potential approval of vibegron and the associated package insert; the clinical utility and potential attributes and benefits of vibegron, including reliance on collaboration partners and the ability to procure additional sources of financing; our intellectual property position, including the ability to identify and in-license or acquire third-party patents and licenses, and associated costs; and other risks and uncertainties listed in the Company’s filings with the
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