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The approval is indicated for children ≥5 years old who inadequately respond to or are intolerant of anticholinergic medication.
The US Food and Drug Administration (FDA) has approved onabotulinumtoxinA (BOTOX) for pediatric detrusor overactivity associated with a neurologic condition.
Granted to AbbVie, the approval is indicated for patients 5 years of age or older and who have inadequately responded to or are intolerant of anticholinergic medication.
“Many children with underlying neurologic conditions may experience bladder and kidney damage over time, which underscores the importance of treatment,” said Paul F. Austin, MD, FAAP, Chief of Pediatric Urology, Texas Children's Hospital and Professor of Urology, Baylor College of Medicine, in a statement.
“When caring for pediatric patients with neurogenic detrusor overactivity, we strive to reduce bladder pressure and increase the bladder's capacity.”
The FDA approval was supported by data from a randomized, double-blind Phase 3 study, which evaluated the safety and efficacy of onabotulinumtoxinA in more than 100 pediatric patients with neurogenic activity.
Investigators demonstrated that intradetrusor administration of 200 units of onabotulinumtoxinA (no more than 6U/kg) reduced daytime urinary incontinence episodes, the primary endpoint of the study.
Additionally, therapy lowered maximum bladder pressure and increased bladder capacity at week 6.
The most common adverse reactions associated with treatment were bacteriuria (20%), urinary tract infection (7%), leukocyturia (7%), and hematuria (3%).
"Botox is the first neurotoxin approved for use in treating neurogenic detrusor overactivity in children who are not adequately managed with anticholinergic medication,” said Mitchell Brin, MD, Senior Vice President, Chief Scientific Officer, Botox & Neurotoxins, AbbVie.
“While always satisfying to bring forth new indications, it is particularly rewarding when we can help advance care for pediatric patients with Botox," he continued.
This approval marks the 12th time the FDA has approved onabotulinumtoxinA for a therapeutic indication, including chronic migraine, overactive bladder, cervical dystonia, and severe underarm sweating, among others.