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Allergan gets US approval for Botox in overactive bladder

Could add $200m to annual sales

Allergan Botox 

The US Food and Drug Administration has expanded the approved use of Allergan's Botox to treat adults with overactive bladder (OAB), a new indication that could add $200m or more to its annual sales.

Botox (onabotulinumtoxinA) has been given a green light to treat idiopathic OAB in people who are not able to be treated using anticholinergic drugs, adding to its existing approval to treat OAB caused by neuronal damage, for example as a result of spinal cord injury or multiple sclerosis.

OAB is a condition in which the bladder squeezes too often or squeezes without warning, leading to urinary incontinence, sudden urgent need to urinate and frequent urination. Botox is injected into the bladder muscle and causes it to relax, increasing the bladder's storage capacity and reducing incontinence.

In trials, patients treated with Botox over a 12-week period experienced urinary incontinence an average of 1.6 to 1.9 times less per day than patients treated with placebo. Similarly, Botox-treated patients also needed to urinate on average 1.0 to 1.7 times fewer times per day, and they also expelled around 30mL more urine than the control group.

Botox is already a major product for Allergan as a result of its cosmetic use in reducing the appearance of wrinkles, but is also approved for various medical conditions such as migraine, excessive sweating, neck spasms (cervical dystonia) and upper limb spasticity.

Allergan reported Botox sales of $1.29bn in the first nine months of 2012 and has said it expects full-year sales to be in the region of $1.8bn.

The drug remains the dominant force in its category despite competition from rival products Dysport (abobotulinumtoxinA) from Ipsen, Merz' Xeomin (incobotulinumtoxinA) and Solstice Neurosciences' Myobloc (rimabotulinumtoxinB), with Allergan claiming market share of 75 to 95 per cent, depending on the therapeutic category and region.

Idiopathic OAB affects an estimated 33 million men and women in the US, according to the FDA, and Allergan's chief scientific officer Scott Whitcup said towards the end of last year that approval in this indication will be one of the biggest for the company commercially in the coming months. 

21st January 2013

From: Sales



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