MyrbetriqTreatment for Overactive Bladder
Update: Myrbetriq (mirabegron) Now FDA Approved - June 28, 2012
Astellas Pharma Inc.: Announcement of Regulatory Submission for Mirabegron (YM178), a Treatment for Overactive Bladder, in U.S. and Europe
TOKYO, Aug. 28, 2011 /PRNewswire/ --Astellas Pharma Inc. 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
Posted: August 2011
- FDA Approves Myrbetriq for Overactive Bladder - June 28, 2012
- FDA Advisory Committee Recommends Approval of Mirabegron - Investigational Overactive Bladder Treatment from Astellas - April 5, 2012
- Receipt of Filing Communication Letter from U.S. FDA Regarding Mirabegron (YM178) - November 11, 2011