11 indications for 30 years! FDA approves AbbVie Botox bolibation: Treatment of lower limb spasms caused by cerebral palsy in children!

July 11, 2020 /PRNewswire/ -- AbbVie has announced that the U.SFood and Drug Administration (FDA) has approved a supplemental biologic licensing application (sBLA) to support the expansion of the use of Botox (Paso, generic name: onabotulintoxinA, botulintoxin A) for the treatment of spasms, including lower limb spasms caused by cerebral palsythe label expansion is based on the selective abandonment by Al-Jian (which has been acquired by AbbVie) and another manufacturer of their exclusive market rights to orphan drugs that use their own neurotoxin products to treat pediatric patients with cerebral palsy crampsBotox was first approved in June 2019 for the treatment of pediatric patients with upper limb spasms, and in October 2019 for the treatment of pediatric patients with lower limb spasms, but not the spasms caused by cerebral palsyspasms are a debilitating neurological disorder that involves muscle stiffness and can cause muscle tension in the upper and lower limbsseverity ranges from light to heavy, often interfering with normal muscle movement and functionthis can lead to delays or developmental disordersCommon causes ofchildhood cramps include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and strokethe most common cause of children's lesions is cerebral palsy, which is estimated to be at about 2.5 per 1,000 live births worldwidealmost all cerebral palsy patients have impaired motor function, and spasms affect up to 91% of childrenthe safety and effectiveness ofBotox's treatment of lower limb spasms in pediatrics was supported by a Phase III study that included more than 300 pediatric patients (2-17 years old) with lower limb spasms caused by cerebral palsythese trials include a 12-week double-blind study and a one-year open-label expansion study"Cerebral palsy is the most common cause of pediatric cramps and has a profound impact on children's development and quality of life," said Mitchell FBrin, Senior Vice President and Chief Scientific Officer ofAbervey Botox and Neurotoxins due to its safety and efficacy, we are pleased that Botox is now now more widely supportive of doctors in treating childhood spasms Building on our 30 years of Botox research and development efforts, we will continue to work on neurotoxin innovation and introduce new treatments to promote the care of pediatric patients, which is particularly worth while we continue to do so "Botox" was developed by ElJian, whose main ingredient is highly purified botulinum toxin Type A, a neurotransmitter used to treat overactive muscles Botox was first approved in 1989 for the treatment of face spasms and squinting, and was approved in 2000 for neck dystonia, which has since expanded into the beauty field, including wrinkle removal, thin face, removal of eyebrow lines and fishtail patterns in recent years, Botox has also been approved for treatment of upper limb spasms, chronic migraines, neuroincontinence, bladder hyperactivity, cramps and severe underarm sweating (hyperperchon) in the United States, Botox has been approved by the FDA for 11 treatments for indications Over the past 30 years, more than 100 million bottles of Botox ® and Botox ® Cosmetic (Botox A) have been sold worldwide, and more than 3,700 articles have been published in scientific and medical journals Botox ® neurotoxins are among the most widely studied drugs in the world () Original origin: FDA Approves Expanded BOTOX? (onabotulinumtoxinA) Label for the treatment of the pediatric patients with Spasticity.