LONDON - Botox, the anti-wrinkle drug, has won a green light in Europe for treating certain patients with urinary incontinence, opening up a potentially important new market for its maker Allergan .
The US group said on Monday that the Irish Medicines Board had given a positive recommendation for Botox to treat patients with overactive bladder problems caused by multiple sclerosis and spinal cord injury.
The move clears the way the approval of the drug in 14 countries, under the European Union's mutual recognition procedure.
Botox, whose active ingredient is a toxin that blocks nerve signals, gets about half its sales from reducing wrinkles. It is also approved to prevent migraine headaches, to reduce excessive sweating, to treat upper limb spasticity, and to help with neck pain and certain types of eye muscle problems.
The European endorsement for the latest indication follows clinical trials suggesting a single injection of Botox into the bladder can provide significant relief for up to nine months. It works reducing involuntary contractions and increasing bladder capacity.
The medicine offers a new option for patients whose bladder problems are not well controlled by the standard treatment of taking pills called anticholinergics, including oxybutynin and Astellas and GlaxoSmithKline's Vesicare.
Allergan expects to get a similar approval from US regulators later this year and, in the long term, the company also hopes to market Botox to a broader population of patients with overactive bladder.
Chief Executive David Pyott last week highlighted overactive bladder as the next big opportunity for the drugmaker's flagship product, which had sales of US$418 million (S$510 million)in the second quarter.
He declined to forecast sales of Botox for overactive bladder but said industry analysts were projecting annual sales of up to $500 million - a substantial amount for a company with a revenue base of US$5.2-5.4 billion.
Between 60-80 per cent of people with multiple sclerosis and 75-80 per cent of people with spinal cord injury have some degree of bladder dysfunction, according to figures cited by Allergan.
In Europe, there are around 650,000 people living with multiple sclerosis and on average 11,000 people are diagnosed with spinal cord injury each year.
Douglas Ingram, Allergan's European head, said the US company would now be working closely with national health authorities to get Botox on to the market in Europe for the new use as quickly as possible.