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).

Source:

Biospace Inc.