Astellas Pharma Inc. announced the submission of a New Drug Application and Market Authorisation Application for mirabegron (generic name/code name:YM178) to the US 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 US 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.
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 5-mg dose is well tolerated, the dose may be increased to 10 mg once daily.