Botox (Allergan) approved in Ireland for treating Overactive Bladder, the first step towards EU-wide approval

Botox (botulinum toxin type A), from Allergan, has received a positive opinion from the Irish Medicines Board for the treatment of idiopathic Overactive Bladder with symptoms of urinary incontinence, urgency and frequency in adult patients who have an inadequate response to, or are intolerant of, anticholinergic medications. Ireland serves as the Reference Member State in the Mutual Recognition Procedure that involves Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain and Sweden. This is an important step towards securing national licences in these 14 European countries. The opinion is based on two multi-centre Phase III trials (the EMBARK studies) involving over 1,100 patients in which patients who received injections of Botox into the bladder muscle experienced a significant and clinically relevant response to treatment compared to placebo in the reduction of urinary incontinence, including more patients becoming dry (no urinary leakage at 12 weeks).