AbbVie Reports the US FDA’s Acceptance of BOTOX’s sBLA for Pediatric Patients with Neurogenic Detrusor Overactivity

Shots:

• The US FDA has accepted the Allergan’s sBLA to expand the BOTOX prescribing information for treating detrusor (bladder muscle) overactivity associated with an underlying neurologic condition in pediatric patients aged 5 -17yrs who have an inadequate response to or are intolerant of, or for any reason unwilling to continue anticholinergic medication
• The sBLA is based on P-III study assessing BOTOX in 100+ pediatric patients with neurogenic detrusor overactivity and a long-term extension study. The company anticipates the PDUFA date to be in Q1’21 following a standard 10-mos. review
• BOTOX is the first and only neurotoxin approved to treat leakage of urine (incontinence) due to overactive bladder caused by a neurologic condition in adults who still have leakage or cannot tolerate the side effects after trying an anticholinergic medication

Click here to read full press release/ article | Ref: AbbVie | Image: Pharmaceutical Technology