Allergan’s Botox receives MHRA backing for incontinence

Allergan has been granted a Medicines and Healthcare Products Regulatory Agency (MHRA) licence for the use of Botox as a treatment for urinary incontinence among certain patient groups in the UK.

The drug has been approved for use in patients with neurogenic detrusor overactivity due to traumatic or non-traumatic subcervical spinal cord injury or multiple sclerosis who are not adequately managed with anticholinergics.

This authorisation is specific to the botulinum toxin type-A product and is based on positive data from the phase III study programme Dignity, which involved two pivotal trials among nearly 700 patients.

Douglas Ingram, president of Allergan in the EMEA region, said: "For people with spinal cord injury or multiple sclerosis, gaining effective control over their bladder and staying dry can be a significant step towards improving overall quality of life."

Botox is Allergan's most successful current product, with the company's forecasts suggesting that the drug will generate net sales of $1.76 billion to $1.8 billion (1.09 billion to 1.12 billion pounds) this year.