UK MHRA licenses Allergan's Botox for use in patients with overactive bladder

Botox (botulinum toxin type A), from US drugmaker Allergan (NYSE: AGN), has been licensed by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the management of bladder dysfunctions in adult patients with overactive bladder (OAB).

The injections have been approved for patients with symptoms of urinary incontinence, urgency and frequency and who are not adequately managed with anticholinergics. The use of Botox in the management of these patients is recommended by the UK’s National Institute for Health and Care Excellence (NICE) in its guidelines on Urinary Incontinence. This is the 10th indication for Botox in the UK and the only botulinum toxin indicated for the management of bladder dysfunctions in this country. When used in the treatment of OAB, Botox works by helping to relax the bladder muscle which minimizes sudden contraction and reduces leakage. It also targets the nerves controlling the sensation of urgency.

Paul Navarre, president of Allergan Europe, Africa, Middle-East, said: “We are pleased that Botox has received the green light from the MHRA for the treatment of overactive bladder in patients who are struggling to control their symptoms with anticholinergic medications. This authorization recognizes Allergan’s long standing commitment to innovation in botulinum toxin research. With two licenses for bladder dysfunction as well as on-going R&D investment, Allergan is emerging as a global specialty leader in urology.”