Astellas Pharma OAB drug gets Japanese approval
Astellas Pharma has received Japanese approval to market Betanis tablet (generic name:mirabegron) as a treatment of urinary frequency, urgency and urge urinary incontinence related to overactive bladder (OAB).
Discovered and developed by Astellas, Betanis tablet improves urine collection function by activating ß3-adrenoceptor selectively on the bladder's smooth muscles, relaxing bladder and improving OAB disorder.
Betanis tablet Phase 3 trial met objective and has showed efficacy in mirabegron treatment groups in mean change from baseline in number of micturitions per 24-hour (primary endpoint) compared to placebo.
Further, the company expects to file this product with the US Food and Drug Administration and European Medicines Agency in 2Q fiscal year 2011.
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