FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for Treatment of Pediatric Spasticity Including Cerebral Palsy-Related Lower Limb Spasticity

July 11, 2020 /BioValleyBIOON/ -- AbbVie recently announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to support the expanded use of Botox (Bao Tuo Shi; generic name: onabotulinumtoxinA, botulinum toxin type A) for the treatment of spasticity in children aged 2 years and older, including lower limb spasticity caused by cerebral palsy.

This label expansion is based on the selective waiver by Allergan (acquired by AbbVie) and another manufacturer of their respective orphan drug market exclusivities for the use of their neurotoxin products in treating spasticity caused by cerebral palsy in pediatric patients.

Botox was first approved in June 2019 for the treatment of pediatric patients with upper limb spasticity, and in October 2019 for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy.

Spasticity is a debilitating neurological disorder characterized by muscle stiffness, which can lead to tightness in the muscles of the upper and lower limbs. Its severity ranges from mild to severe and often interferes with normal muscle movement and function. This may result in delayed postural development or developmental impairments. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, andStroke。

The most common cause of focal spasticity in children is cerebral palsy, which is estimated to affect approximately 2.5 per 1,000 live births globally. Nearly all individuals with cerebral palsy have motor function impairments, with spasticity affecting up to 91% of affected children.

The safety and efficacy of Botox in the treatment of pediatric lower limb spasticity are supported by a Phase III study that enrolled more than 300 pediatric patients (aged 2–17 years) with lower limb spasticity caused by cerebral palsy. These trials included a 12-week double-blind study and a one-year open-label extension study.

“Cerebral palsy is the most common cause of spasticity in children, profoundly impacting their development and quality of life,” said Mitchell F. Brin, M.D., Senior Vice President of Botulinum Toxin and Neurotoxins and Chief Scientific Officer at AbbVie. “Given its safety and efficacy profile, we are pleased that Botox can now more broadly support physicians in treating pediatric spasticity. Building on our 30-year commitment to Botox research and development, we remain dedicated to innovating in neurotoxins and introducing new therapies to enhance care for pediatric patients, which is particularly rewarding.”

Botox (Botox), developed by Allergan, has highly purified botulinum toxin type A as its active ingredient. It is 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.

In the United States, to date, Botox has beenFDAApproved for 11 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)

Original Source:FDA Approves Expanded BOTOX? (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity