Ipsen Announces FDA Approval of Dysport for Upper Limb Spasticity in Children Aged 2+ with Cerebral Palsy

July 13, 2020 News /BioValleyBIOON/ -- Ipsen Biopharmaceuticals, a subsidiary of the French pharmaceutical company Ipsen (ipsen BioPharmaceuticals) recently announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of the indications for Dysport (Chinese name: Lishutuo, abobotulinumtoxinA, botulinum toxin type A) injection for the treatment of upper and lower limb spasticity in children aged 2 years and older, including spasticity caused by cerebral palsy (CP).

2016,FDAUpon the initial approval of Dysport for the treatment of lower limb spasticity in children,ipsIpsen was granted orphan drug market exclusivity for Dysport in the treatment of pediatric patients with lower limb spasticity caused by cerebral palsy (CP). In 2019,FDAApproval of Dysport for the treatment of upper limb spasticity in children aged 2 years and older, excluding upper limb spasticity caused by cerebral palsy (CP), was granted because another pharmaceutical company (Allergan, acquired by AbbVie) was awarded orphan drug market exclusivity for Botox in the treatment of pediatric patients with upper limb spasticity due to cerebral palsy (CP).

Ipsen collaborated with the FDA and AbbVie, selectively waiving their respective market exclusivity rights to better support patient care. Consequently, the FDA has now approved Dysport for the treatment of upper and lower limb spasticity in children aged 2 years and older, including upper limb spasticity caused by cerebral palsy (CP). Meanwhile,FDAAlso approved the label update for AbbVie’s botulinum toxin product Botox (Botox, generic name: onabotulinumtoxinA, botulinum toxin type A) for the treatment of upper and lower limb spasticity in children aged 2 years and older, including lower limb spasticity caused by cerebral palsy.

Sarah Helen Evans, MD, Director of the Department of Pediatric Rehabilitation Medicine at Children’s Hospital of Philadelphia, stated: “Addressing the uncertainties associated with the previous classification of cerebral palsy is a positive step that enables us, as physicians, to prescribe consistent treatment regimens for pediatric patients experiencing spasticity in both the upper and lower limbs. This update to the drug labeling ensures patient care by treating children holistically, which will become the focal point for physicians and caregivers when deciding on treatments for upper and lower limb spasticity.”

ipsKimberly Baldwin, Vice President of the Neuroscience Business Unit and Franchise Lead, said, “We are proud to proactively engage withFDA“Collaborating with other manufacturers to help physicians treat patients in the manner they deem most beneficial for patient care. This effort underscores our ongoing commitment to patients, helping to ensure that children with cerebral palsy receive the spasticity treatment best suited to their needs.”

Spasticity is a debilitating neurological disorder involving 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 worldwide. Nearly all individuals with cerebral palsy have motor function impairments, with spasticity affecting up to 91% of affected children.

Dysport is an injectable botulinum toxin type A (BoNT-A) purified and isolated from Clostridium bacteria that produce BoNT-A, and it is provided as a lyophilized powder. In the United States, Dysport has been approved for the treatment of cervical dystonia (CD) in adults and for the treatment of spasticity in adults. Dysport is alsoFDAThe first botulinum toxin product approved for the treatment of upper and lower limb spasticity in children aged 2 years and older.

Dysport, like all botulinum toxin products, carries a boxed warning indicating that the effects of botulinum toxin may spread from the injection site to other parts of the body, causing symptoms similar to botulism. These symptoms include difficulty swallowing and breathing, which can be life-threatening. Dysport is contraindicated in patients with a known hypersensitivity to any botulinum toxin preparation or any of its components, in patients with infection at the proposed injection site, and in patients with a known allergy to cow's milk protein. The potency units of Dysport are specific to the preparation and assay method used and are not interchangeable with those of other botulinum toxin products. (Bioon.com)

Original Source:Ipsen Announces Updated Indication for Dysport (abobotulinumtoxinA) for the Treatment of Spasticity in Children