FDA approves Ipsos Dysport: Treatment of upper limb spasms caused by cerebral palsy in children as young as 2 years of age.

In 2016, when the FDA first approved Dysport's treatment of lower limb spasms in children, Ipsen was granted the exclusive market for orphan drugs that Dysport uses to treat children with lower limb spasms caused by cerebral palsy (CP).
In 2019, the FDA approved Dysport for the treatment of upper limb spasms in children 2 years of age and older, excluding upper limb spasms caused by cerebral palsy (CP), as another pharmaceutical company (Aljian, acquired by AbbVie) was granted exclusive market access to Botox's orphan drug for children with upper limb spasms caused by cerebral palsy (CP).
has worked with the FDA and AbbVie to selectively relinquish their market exclusive rights to better support patient care.
, the FDA has now approved Dysport's treatment of upper and lower limb spasms in children 2 years and older, including those caused by cerebral palsy (CP).
At the same time, the FDA approved a product label update for the AbbVie botulin toxin product Botox (Prudential, generic name: onabotulinumtoxinA, Botox A) for the treatment of upper and lower limb spasms in children 2 years and older, including lower limb spasms caused by cerebral palsy.
"Addressing the uncertainty caused by the previous division of cerebral palsy is a positive step that allows us, as doctors, to develop a consistent treatment plan for pediatric patients who experience upper and lower limb spasms," said Sarah Helen Evans, M.D., director of pediatric rehabilitation medicine at Children's Hospital of Philadelphia.
this drug label update ensures patient care and treats children as a whole, which will be the focus of doctors and child caregivers in deciding on the treatment of upper and lower limb spasms.
Re proud to work with the FDA and other manufacturers to help doctors treat patients in the way they think is best for patient care," said Kimberly Baldwin, vice president and franchise director of the neuroscience division at ipsen.
this effort demonstrates our continued commitment to patients and helps ensure that children with cerebral palsy have access to the spasm treatment that best suits them.
" spasms are a debilitating neurological condition involving muscle stiffness that can lead to muscle tightness in the upper and lower limbs.
from light to heavy, often interfere with normal muscle movement and function.
this can lead to posture delays or developmental disorders.
common causes of childhood spasms include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury and stroke.
cause of childhood lesions is cerebral palsy, which is estimated to occur globally for every 1,000 live births.
almost all people with cerebral palsy have impaired motor function, and spasms affect up to 91% of children.
Dysport is an injectable type A botulinum toxin type A, BoNT-A, which is isolated and purified from Bacillus difficile, which produces Bont-A, and is provided as freeze-dried powder.
the United States, Dysport has been approved for the treatment of cervical vertebral dysfunction (CD) and the treatment of adult spasms.
is also the first FDA-approved Botox product to treat upper limb and lower limb spasms in children 2 years and older.
Dysport and all Botox products have a black box warning that the effects of Botox may spread from the injection site to other parts of the body, causing symptoms similar to Botox poisoning.
these symptoms include difficulty swallowing and breathing, which can be life-threatening.
Dysport is prohibited for use in patients known to be allergic to any botulinum toxin preparation or any ingredient, or to patients with an infection at the intended injection site, or to patients known to be allergic to cow's milk protein.
Dysport's units of effectiveness are related to the preparation and analysis methods used and are not interchangeable with other preparations of botulinum toxin products.
original origin: Ipsen Announces Updated Indicator for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children Original title: New drug for children with cerebral palsy spasms! FDA approves Ipsos Botulinum Toxin Dysport: Treatment of upper limb spasms caused by cerebral palsy in children as young as 2 years old!