New data support efficacy of Astellas' mirabegron for overactive bladder

Mirabegron is a first-in-class beta-3 adrenoceptor agonist, taken as a once-daily tablet, which helps the bladder fill and retain urine.

Last November, Astellas said that the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) had started their reviews of mirabegron, which is already approved in Japan under the Betanis trade name.

A Phase III trial reported at the European Association of Urology (EAU) meeting in Paris, France, indicated that mirabegron was effective in reducing the mean number of incontinence episodes and micturitions in a 24-hour period in antimuscarinic-naive patients as well as those who had discontinued prior antimuscarinic therapy, regardless of the reason for discontinuation.