11th Indications! Fda approves AbbVie Botox for treatment of lower limb spasms caused by cerebral palsy in children.

The label expansion is based on The Market for Orphan Ediguic (which has been acquired by AbbVie) and another manufacturer to selectively waive their respective market exclusive rights to orphan drugs that treat pediatric patients with cerebral palsy-induced spasms using their own neurotoxin products.
Botox 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 palsy.
spasms are a debilitating neurological disorder that involves muscle stiffness and can cause muscle tension in the upper and lower limbs.
severity ranges from light to heavy, often interfering with normal muscle movement and function.
this can lead to delays or developmental disorders. Common causes of
childhood cramps include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke. the most common cause of
children's lesions is cerebral palsy, which is estimated to be at about 2.5 per 1,000 live births worldwide.
almost all cerebral palsy patients have impaired motor function, and spasms affect up to 91% of children.
the safety and effectiveness of Botox's treatment of pediatric lower limb spasms was supported by a Phase III study that enrolled more than 300 pediatric patients (2-17 years old) with lower limb spasms caused by cerebral palsy.
these 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 F. Brin, Senior Vice President and Chief Scientific Officer of
Abervey 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, developed by ElJian, is a highly purified type Botox, 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 Source: FDA Approves Expanded BOTOX? (onabotulinumtoxinA) Label for the treatment of the patient son of Patients with Spasticity original title: 30 years on the market 11 indications! FDA approves AbbVie Botox bolibation: Treatment of lower limb spasms caused by cerebral palsy in children!