COMUNICADO: New Class of Treatment for Overactive Bladder Demonstrates Efficacy and Tolerability Across Three Separate Studies (y 2)

Actualizado 24/02/2012 9:54:13 CET

Mirabegron is a once daily oral selective beta3-adrenoceptor agonist discovered and developed by Astellas. It is the first compound to be submitted for regulatory approval in this new class of treatment, using a novel mechanism of action to antimuscarinics, the current treatment standard.[1] Antimuscarinics work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Mirabegron works by stimulating the beta3 receptors in the detrusor muscle of the bladder[5] causing relaxation of the bladder muscle during the storage phase of the micturition cycle. This improves the storage capacity of the bladder without impeding bladder voiding.[6]

Astellas submitted a New Drug Application and Market Authorisation Application for mirabegron to the U.S. Food and Drug Administration and the European Medicines Agency on August 24 and 26, 24 Feb. (US and Europe, respectively) - . Astellas is seeking approval for the indication of overactive bladder (OAB) associated with symptoms of urgency, urinary frequency, and urge urinary incontinence. In Japan, Astellas was granted marketing approval under the trade name of Betanis(R) tablet in July 2011. Additionally, there is an on-going multiregional Phase 3 study in China, Korea, Taiwan, and India.

About Astellas Pharma Europe Ltd.:

Astellas Pharma Europe Ltd., located in the UK, is a European subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceuticals. The organisation is committed to becoming a global company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. Astellas Pharma Europe Ltd. is responsible for 21 affiliate offices located across Europe, the Middle East and Africa, an R&D site and three manufacturing plants. The company employs approximately 4,200 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.

References


1) Khullar V et al. Efficacy of mirabegron in patients with and without
prior anti-muscarinic therapy for overactive bladder (OAB): Post-hoc analysis of a
prospective, randomised European-Australian phase III trial. EAU 2012 Abstract
AM12-2389: 684
2) Chapple CR et al. Randomised, double blind, active controlled phase III study
to assess the long-term safety and efficacy of mirabegron in overactive bladder. EAU
2012 Abstract AM12-1967:683
3) Martin N et al. Randomised, double-blind, placebo-controlled study to assess
ocular safety of mirabegron in normotensive IOP research subjects. EAU 2012 Poster
AM12-1928: 686
4) Compion G et al. Reasons for switching antimuscarinic therapy: Results from a
European cross-sectional survey of physicians and patients with OAB. EAU 2012 Abstract
AM12-2068: 691
5) Takasu T et al. Effect of (R)-2-(2-aminothiazol-4-yl)-4'-{2-[(
2-hydroxy-2-phenylethyl)amino]ethyl} acetanilide (YM178), a novel selective
beta3-adrenoceptor agonist, on bladder function. J Pharmacol Exp Ther 2007; 321: 642-7
6) Tyagi P et al. Mirabegron: safety review Expert Opin. Drug Safety
2011;10.2:287-294.

CONTACT: For further information please contact: Julia Holt, Red DoorCommunications, jholt@rdcomms.com, Tel: +44(0)20-8392-8052; Mindy Dooa,Astellas Pharma Europe Ltd., Mindy.Dooa@eu.astellas.com, Tel: +44(0)1784-419-408

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