Allergan receives positive EU decision on Botox for overactive bladder

Allergan has been granted a positive opinion for approval of Botox for the treatment of idiopathic overactive bladder (OAB) in 14 European nations.

The Irish Medicines Board, which is assessing the drug in this new indication as part of a European Mutual Recognition Procedure, has recommended the therapy for approval based on positive safety and efficacy data from a successful phase III trial programme.

It has been shown that Botox injections into the bladder muscle can deliver significant and clinically relevant benefits compared to placebo in the reduction of urinary incontinence.

Currently, there are very limited treatment options available for idiopathic OAB patients who have not achieved bladder control with existing anticholinergic medications.

Douglas Ingram, president of Allergan in Europe, Africa and the Middle East, said: "Our task now is to work closely with the national health authorities in Europe to secure the relevant national licences so that we can bring this valuable treatment option to patients."

This comes after the UK's Medicines and Healthcare Products Regulatory Agency licensed Botox for the management of urinary incontinence in adult patients with neurogenic detrusor overactivity due to subcervical spinal cord injury or multiple sclerosis.