Tolterodine Fumarate

CASTRES, France, May 22, 2023 /PRNewswire/ -- Following the exclusive licensing agreement with Urovant Sciences GmbH, Pierre Fabre announced today the start of the EU marketing authorization application procedure (centralized procedure) for Vibegron, a novel, potent, and selective human β3 adrenergic receptor (β 3-AR) agonist inducing muscle relaxation to increase bladder capacity and relieve symptoms of overactive bladder (OAB). The submission is based on positive data from the pivotal, randomized, double-blind, and active (tolterodine)-controlled multicenter Phase 3 studies in patients with symptoms of overactive bladder, Study RVT-901-3003, which assessed the efficacy, tolerability and safety of Vibegron (at a dose of 75 mg) and its extension, Study RVT-901-3004, which assessed the long-term safety, tolerability and efficacy of Vibegron. The results demonstrated that Vibegron possesses multiple favorable qualities that support its use as a new β3-AR agonist for the symptomatic treatment of urgency, increased micturition number and/or urge urinary incontinence as may occur in adult patients with OAB syndrome. The submission also includes clinical data from the study URO-901-1001, a randomized, Phase 1, double-blind, placebo-controlled, parallel-group study in subjects with OAB, designed to study the effect of Vibegron (at a dose of 75 mg or placebo for 28 days) at steady state on ambulatory blood pressure (BP) and heart rate (HR). Results from this study confirm that Vibegron 75 mg had no statistically significant or clinically meaningful effects on BP or HR in patients with symptoms of OAB. "The submission of the Vibegron application to the EMA is another important milestone for Pierre Fabre, which reinforces its long-standing commitment to the field of urology. We look forward to providing an effective and safe therapeutic response to patients suffering from overactive bladder, to bring them a significant improvement in their quality of life, and thus strengthen our raison d'être "Every time we care for a single person, we make the whole world better", said Eric Ducournau, group CEO at Pierre Fabre. For more information about Pierre Fabre, please visit . Urovant Sciences and GEMTESA are trademarks of Urovant Sciences GmbH. Logo: Press contact: Anne Kerveillant [email protected] SOURCE Pierre Fabre

DUBLIN--( BUSINESS WIRE )--The "Overactive Bladder Treatment (OAB) Market by Drug type ( Anticholinergic (Solifenacin, Oxybutynin, Tolterodine, Darifenacin), Mirabegron), Botox, Neuromodulation, Disease Type (Idopathic OAB and Neurogenic OAB) and Region - Global Forecasts to 2027" report has been added to ResearchAndMarkets.com's offering. The global overactive bladder treatment market is projected to reach USD 4.2 billion by 2027 from USD 3.5 billion in 2022, at a CAGR of 3.6% Rising prevalence of overactive bladder across the globe coupled with rising awareness about treatment options available is driving the growth of the market. Additionally, use of neuromodulation techniques for the treatment of OAB is further expected to have a significant positive impact. The adoption of novel treatments and the launch of new drugs for OAB treatment are also likely to support market growth in the coming years. Mirabegron segment dominates the overactive bladder (OAB) treatment market in 2021. Based on type, the overactive bladder treatment market is segmented into anticholinergics, mirabegron, BOTOX, neuromodulation, and other treatments. Mirabegron held a dominant share of the market in 2021, owing to the lesser side-effects associated with this drug compared to other drug classes available in the market. Furthermore, neuromodulation segment is expected to grow at faster pace owing to launch of new SNM & PTNS for OAB in market. The idiopathic overactive bladder segment will witness the highest growth in overactive bladder treatment market during the forecast period. Based on disease type, the overactive bladder treatment market is segmented into idiopathic overactive bladder and neurogenic overactive bladder. The idiopathic overactive bladder segment accounted for a larger market share due to the higher prevalence of idiopathic overactive bladder disorders and increased use of drugs for the treatment. North America held dominant share in 2021. In 2021, North America accounted for the major share in the OAB treatment market. North America holds majority of the key market players leading to maturity of OAB treatment market in this region. Furthermore, favorable reimbursement policies in US is one of the leading factor projecting market growth in North America. Competitive landscape The prominent players in this market are Astellas Pharma Inc. (Japan), Teva Pharmaceutical Industries Ltd. (Israel), Pfizer Inc. (US), Medtronic Plc (Ireland), AbbVie Inc. (US), Viatris Inc. (US), Hisamitsu Pharmaceutical Co., Inc. (Japan), Johnson & Johnson Services, Inc. (US), and Endo Pharmaceuticals Inc. (Ireland). Market Dynamics Market Drivers Rising Prevalence of Overactive Bladder Syndrome Rapidly Aging Population and Subsequent Rise in Incidence of Diseases Characterized by Oab Development and Use of Innovative Intravesical Therapies Growing R&D Investments and the Launch of Novel Therapies in the Coming Years Market Restraints Frequent Product Recalls Increased Side-Effects of Anticholinergic Drugs Market Opportunities Novel Treatments, Robust Pipelines, and Patent Cliff of Certain Drugs Market Challenges Social Stigma and Lack of Awareness About OAB Companies mentioned: Abbvie Inc Ajanta Pharma Altherx Pharmaceuticals Amneal Pharmaceuticals LLC Apotex Inc Astellas Pharma Inc Bayer Ag Endo Pharmaceuticals Inc Glenmark Granules India Limited Hisamitsu Pharmaceutical Co Inc Hugel, Inc Intas Pharmaceuticals Ltd Johnson & Johnson Services, Inc Laborie Lupin Macleods Pharmaceuticals Ltd Medtronic Medytox Pfizer Inc Sun Pharmaceutical Industries Ltd Taiho Pharmaceutical Co Ltd Teva Pharmaceutical Industries Ltd Urovant Sciences Viatris Inc For more information about this report visit https://www.researchandmarkets.com/r/2n1a4y About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.