EU approves Betmiga (Astellas) for the treatment of Overactive Bladder

Betmiga (mirabegron), from Astellas, has received approval from the European Commission for the treatment of Overactive Bladder (OAB) symptoms in adults. The European Commission granted approval of mirabegron following the recommendation by the CHMP in October 2012. They reviewed extensive clinical trial evidence from 7 Phase II / III studies in which over 5,000 patients received mirabegron, including 3 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. In the trials, mirabegron was also well tolerated and exhibited a good safety profile.