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https://www.marketwatch.com/story/a...muscles-in-adult-spasticity-abbv-271627562898
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Big pharma’s Botox get FDA approval for more muscles in adult spasticity
- Thread starter ginfreely
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By Colin Kellaher
AbbVie Inc.'s Allergan unit Thursday said the U.S. Food and Drug Administration approved the expanded use of Botox to include eight new muscles for the treatment of upper limb spasticity in adults.
Allergan said the approval covers additional muscles of the elbow and forearm, along with intrinsic hand muscles and thumb muscles.
AbbVie Inc.'s Allergan unit Thursday said the U.S. Food and Drug Administration approved the expanded use of Botox to include eight new muscles for the treatment of upper limb spasticity in adults.
Allergan said the approval covers additional muscles of the elbow and forearm, along with intrinsic hand muscles and thumb muscles.
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The company said Botox's label now also includes the use of ultrasound as a muscle localization technique in adult spasticity, which is commonly caused by stroke, multiple sclerosis, spinal-cord injury, cerebral palsy and traumatic brain injury.
Botox, which the FDA first approved in 1989 for a pair of rare eye muscle disorders, is currently FDA-approved for a dozen therapeutic indications.
AbbVie, a North Chicago, Ill., biopharmaceutical company, completed its roughly $63 billion acquisition of Allergan last year.
Write to Colin Kellaher at [email protected]
Botox, which the FDA first approved in 1989 for a pair of rare eye muscle disorders, is currently FDA-approved for a dozen therapeutic indications.
AbbVie, a North Chicago, Ill., biopharmaceutical company, completed its roughly $63 billion acquisition of Allergan last year.
Write to Colin Kellaher at [email protected]
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https://www.hcplive.com/view/fda-approves-botox-label-expansion-upper-limb-spasticity
Jonathan Alicea
The US Food and Drug Administration (FDA) has approved a label expansion of onabotulinumtoxinA (Botox) to include 8 new muscles in the treatment of upper limb spasticity in adults.
These additional muscles are brachialis, brachioradialis, pronator teres, and pronator quadratus in the elbow and forearm; lumbricals and interossei in the hand; and flexor pollicis brevis and opponens pollicis in the thumb.
The expanded label also includes the use of ultrasound as a muscle localization technique for these patients.
"Today's announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient's quality of life," said Mitchell Brin, MD, Senior Vice President and Chief Scientific Officer of BOTOX® & Neurotoxins at AbbVie, in a statement.
"This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients."
Botox Label Expansion for Upper Limb Spasticity
July 29, 2021Jonathan Alicea
The US Food and Drug Administration (FDA) has approved a label expansion of onabotulinumtoxinA (Botox) to include 8 new muscles in the treatment of upper limb spasticity in adults.
These additional muscles are brachialis, brachioradialis, pronator teres, and pronator quadratus in the elbow and forearm; lumbricals and interossei in the hand; and flexor pollicis brevis and opponens pollicis in the thumb.
The expanded label also includes the use of ultrasound as a muscle localization technique for these patients.
"Today's announcement is especially important because spasticity is a disabling neurological condition that can have a significant impact on a patient's quality of life," said Mitchell Brin, MD, Senior Vice President and Chief Scientific Officer of BOTOX® & Neurotoxins at AbbVie, in a statement.
"This label expansion not only adds to our rich history in neurotoxin science, but also reinforces the role of BOTOX® in upper limb spasticity treatment. BOTOX® provides an evidence-based dosing strategy to meet the clinical needs of providers and their patients."
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About Upper Limb Spasticity
Adults may develop spasticity following stroke, multiple sclerosis, spinal cord injury, cerebral palsy, and traumatic brain injury. Such individuals are likely to experience stiffness in the muscles of their upper and/or lower limbs and may lose voluntary control of them.Signs of upper limb spasticity include a bent elbow, an arm pressed against the chest, or a curled-in hand with a clenched fist. These can lead to difficulty with posture and positioning and can largely impact the patient’s daily functioning and activities.
It is estimated that 6.7 million adults in the United States live with spasticity across a variety of neurologic conditions.
OnabotulinumtoxinA is currently approved for treatment of spasticity in patients 2 years of age and older.
