US FDA accepts Supplemental Biologics License Application (sBLA) for Botox (onabotulinumtoxinA) for the treatment of paediatric patients with neurogenic detrusor overactivity

The sBLA relates to use in children aged 5 -17 years who have an inadequate response to, or are intolerant of, or for any reason unwilling to continue anticholinergic medication and is based on data from RCT (n=100) and a long-term extension study (results not yet published).

SPS commentary:

In the UK botulinum toxin type A is licensed for management of bladder dysfunctions in adult patients only.


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