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Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
Date:8/28/2011

TOKYO, Aug. 28, 2011 /PRNewswire/ -- Astellas Pharma Inc. (Tokyo:4503, "Astellas") 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 B3-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® 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 VESIcare

INDICATION AND DOSAGE

VESIcare tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose of VESIcare is 5 mg once daily. If the
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SOURCE Astellas Pharma Inc.
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