Botox onabotulinumtoxinA regulatory update

Allergan disclosed in its 1Q12 earnings that it submitted a regulatory application to Health Canada for Botox onabotulinumtoxinA to treat overactive bladder (OAB) with symptoms of urinary incontinence, urgency and frequency in adults with an inadequate response to or intolerant of anticholinergic treatment. Earlier this year, Allergan said it submitted an sBLA to FDA in the U.S. and a regulatory application in Europe for Botox treat OAB with symptoms of urinary incontinence, urgency and frequency in adults who have had an inadequate response to or are intolerant to anticholinergic drugs.

The vacuum-dried purified botulinum toxin type A is approved for 25 different indications in about 85 countries. In the U.S., the product is approved to treat urinary incontinence due to neurogenic detrusor overactivity associated with a neurologic condition, severe primary axillary hyperhidrosis, cervical dystonia and strabismus, blepharospasm associated with dystonia, upper limb spasticity and chronic migraine. Botox is approved in the U.K. in adults to treat severe axillary hyperhidrosis of the armpits, cervical dystonia, blepharospasm, hemifacial spasm and post-stroke spasticity in the hand and wrist and to prevent chronic migraine. The product is also approved in the U.K. to treat dynamic equinus foot deformity in children >=2 years with cerebral palsy. ...