CHMP recommends Betmiga (Astellas) for patients with Overactive Bladder - 21-Oct-2012

The CHMP has adopted a positive opinion, recommending the granting of a marketing authorisation for Betmiga (mirabegron), from Astellas, for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with Overactive Bladder (OAB) syndrome. If approved, mirabegron will be the first in a new class of OAB treatment, offering healthcare professionals an alternative option to antimuscarinics (currently the only licensed oral treatment option) when treating patients with OAB.

The CHMP reviewed comprehensive clinical trial evidence from 7 Phase II / III studies in which over 5,000 patients received mirabegron, including three Phase III double-blind, randomised controlled trials conducted in the US and Europe-Australia. In the trials, mirabegron demonstrated superior efficacy compared to placebo in the treatment of symptoms of OAB, with patients needing to visit a toilet significantly less frequently and experiencing fewer incontinence episodes.

The drug is approved in the U.S. as Myrbetriq .