BOTOX® Receives FDA Approval for 12th Indication: Treatment of Pediatric Neurogenic Detrusor Overactivity
Feb 16, 2021 23:59
CST Updated
23:59
AbbVie
Innovative Drug Developer
FDA
U.S. Food and Drug Administration
February 16, 2021 News /BioValleyBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved Botox (Botox, generic name: onabotulinumtoxinA, botulinum toxin type A) for the treatment of detrusor (bladder muscle) overactivity associated with neurological conditions in pediatric patients aged ≥5 years who have an inadequate response to or are intolerant of anticholinergic medications.This milestone marks the 12th therapeutic indication for which Botox has been approved in the United States.
It is worth noting that Botox is the first and only neurotoxin approved for the treatment of pediatric patients with neurogenic detrusor overactivity. Now, for pediatric patients with neurogenic detrusor overactivity who have an inadequate response to anticholinergic medications, there is a new therapeutic option available prior to surgical intervention.。Botox selectively inhibits the release of the neurotransmitter acetylcholine at the neuromuscular junction by blocking the transmission of nerve impulses to muscles (in this indication, the bladder muscle), thereby temporarily reducing muscle contraction.
Neurogenic Detrusor OveractivityNeurogenic detrusor overactivity occurs when the spinal cord and bladder fail to communicate effectively, a condition often associated with neurological disorders such as spina bifida and spinal cord injury. As a result, the bladder muscle contracts involuntarily, leading to increased intravesical pressure and reduced bladder capacity, which causes frequent and involuntary urine leakage in patients. Over time, elevated bladder pressure can also result in damage to both the bladder and the kidneys.
Pediatric neurogenic detrusor overactivity has multiple causes, such as rhabdomyositis, spinal cord injury, and spina bifida; among these, spina bifida is the most common, affecting approximately 1,500–2,000 infants among the more than 4 million born annually in the United States. Over 90% of patients with spina bifida exhibit urological symptoms.
The approval of this new indication is based on data from a randomized, double-blind Phase 3 study. This study was conducted in more than 100 pediatric patients with neurogenic detrusor overactivity (NDO) to evaluate the safety and efficacy of Botox®, and included a long-term extension study. The results of the Phase 3 study demonstrated that intradetrusor injections of Botox® 200 Units (not exceeding 6 U/kg) reduced the frequency of daytime urinary incontinence episodes, which was the primary endpoint of the study, and decreased maximum detrusor pressure and increased bladder capacity at Week 6 (the primary timepoint). The most commonAdverse Reactionsbacteriuria (20%), urinary tract infection (7%), pyuria (7%), and hematuria (3%).
Neurogenic Detrusor Overactivity (Image source: epainassist.com)
Mitchell F. Brin, M.D., Senior Vice President and Chief Scientific Officer of BOTOX® & Neurotoxins at AbbVie, stated, “Botox is the first neurotoxin approved for children with neurogenic detrusor overactivity (NDO) whose condition is inadequately controlled with anticholinergic medications. This milestone marks the 12th therapeutic indication for Botox approved in the United States, adding another approved use to our pediatric portfolio. Building on our 30-year legacy of Botox research and development, we remain steadfast in our pursuit of neurotoxin innovation to address unmet medical needs across the therapeutic area.”
“Many children with underlying neurological conditions may develop bladder and kidney damage over time, highlighting the importance of treatment,” said Paul F. Austin, M.D., Professor of Urology at Baylor College of Medicine and Chief of Pediatric Urology at Texas Children’s Hospital. “In caring for pediatric patients with neurogenic detrusor overactivity, we strive to reduce bladder pressure and increase bladder capacity. Previously, apart from surgery, treatment options were largely limited to anticholinergic medications, which require careful consideration for long-term use. Effective management of neurogenic detrusor overactivity necessitates ongoing care, and there is a significant unmet need for alternative therapeutic options. With its proven safety and efficacy, Botox offers a new treatment option for pediatric patients whose condition is not adequately managed with anticholinergic medications.”
Botox (Botox), developed by Allergan (now acquired by AbbVie), contains highly purified botulinum toxin type A as its active ingredient. It acts as a neuromuscular blocking agent used to treat overactive muscles. Botox was first approved in 1989 for the treatment of blepharospasm and strabismus, and later approved in 2000 for cervical dystonia. Its indications have since expanded into the aesthetic field, including wrinkle reduction, facial slimming, and the elimination of glabellar lines and crow’s feet. In recent years, Botox has also been approved for multiple additional indications, such as upper limb spasticity, chronic migraine, neurogenic urinary incontinence, overactive bladder, spasticity, and severe primary axillary hyperhidrosis (excessive underarm sweating).
Botox is the first approved type A botulinum toxin therapeutic product worldwide. In the United States, to date, Botox has beenFDAApproved for 12 therapeutic indications. Over the past 30 years, more than 100 million vials of Botox® and Botox® Cosmetic (onabotulinumtoxinA) have been sold worldwide, with over 3,700 articles published in scientific and medical journals. Botox® neurotoxin is one of the most extensively studied drugs globally. (Bioon.com)