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news.Astellas Pharma has submitted mirabegron’s new drug application and market authorisation application with the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
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Mirabegron is a once daily oral selective B3-adrenoceptor agonist discovered and developed by Astellas.
The company is seeking approval for the indication of overactive bladder (OAB) associated with symptoms of urgency, urinary frequency and urge urinary incontinence.
The pivotal Phase 3 clinical trials in the US and Europe met primary endpoints compared to placebo.
In Japan, Astellas was granted marketing approval under the trade name of Betanis tablet in July 2011.
Further, there is an on-going multiregional Phase 3 study in China, Korea, Taiwan and India.