FDA Approves Botox for Pediatric Detrusor Neurogenic Overactivity | HCPLive

The United States Food and Drug Administration (FDA) has approved onabotulinumtoxinA (BOTOX) for pediatric detrusor overactivity associated with neurological disease.

Granted to AbbVie, the approval is indicated for patients 5 years of age or older who have responded inadequately or who are intolerant to anticholinergic drugs.

“Many children with underlying neurological conditions can experience bladder and kidney damage over time, which underscores the importance of treatment,” said Paul F. Austin, MD, FAAP, chief of staff. pediatric urology, Texas Children’s Hospital and professor of urology, Baylor College of Medicine, in a statement.

“When treating pediatric patients with neurogenic detrusor overactivity, we strive to reduce bladder pressure and increase bladder capacity.

The FDA approval was supported by data from a phase 3, randomized, double-blind study, which evaluated the safety and efficacy of onabotulinumtoxinA in more than 100 pediatric patients with neurogenic activity.

The researchers demonstrated that the intradetrusor administration of 200 units of onabotulinumtoxinA (no more than 6 U / kg) reduced episodes of daytime urinary incontinence, the primary endpoint of the study.

Additionally, treatment reduced peak bladder pressure and increased bladder capacity at week 6.

The most common side effects associated with treatment were bacteriuria (20%), urinary tract infection (7%), leukocyturia (7%) and hematuria (3%).

“Botox is the first neurotoxin approved for use in the treatment of neurogenic detrusor overactivity in children who are not properly managed with anticholinergic drugs,” said Mitchell Brin, MD, senior vice president, scientific director , Botox and neurotoxins, AbbVie.

“While always satisfying to come up with new indications, it is particularly gratifying to be able to help advance the care of pediatric patients with Botox,” he continued.

This approval marks the twelfth time that the FDA has approved onabotulinumtoxinA for a therapeutic indication, including chronic migraine, overactive bladder, cervical dystonia, and severe underarm sweating, among others.