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Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
Staines, England (ots/PRNewswire) - Astellas Pharma Inc. [http://www.astellas.com/en/corporate] today announced the submission of a New Drug Application and Market Authorisation Application for mirabegron (generic name / code name: YM178) to the U.S. Food and Drug Administration and the European Medicines Agency. The submissions were sent on August 24 and 26, 2011 (Europe and US, respectively). Astellas is seeking approval for this first in a new class of medicine for the indication of overactive bladder (OAB*) associated with symptoms of urgency, urinary frequency, and urge urinary incontinence.
Mirabegron is a once daily oral selective beta3-adrenoceptor agonist discovered and developed by Astellas. The pivotal Phase 3 clinical trials in the U.S. and Europe met primary endpoints compared to placebo.
Astellas has been developing mirabegron as a global project. 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.
Astellas markets the OAB medication solifenacin succinate (known as Vesicare) in **67 countries/areas and has contributed to improving OAB associated symptoms.
*OAB is associated with symptoms such as urinary frequency, urgency, nocturia and urge incontinence. In the U.S. and Europe, >12% of adults and 30-40% of adults 75 years of age and over are estimated to have some sort of OAB symptoms (Wein AJ, Rovner ES. The overactive bladder: an overview for primary care health providers. Int J Fertil Womens Med. 1999;44:56-66).
** as of July 2011
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 4,000 staff across these regions. For more information about Astellas Pharma Europe, please visit http://www.astellas.eu.
For inquiries or additional information: Astellas Pharma Inc.,
Corporate Communications, Tel: +81-3-3244-3201, Fax: