AbobotulinumtoxinA Label Expanded to Include Upper, Lower Limb Spasticity Caused By Cerebral Palsy

July 15, 2020

Previous exclusions limiting use of the drug in spasticity caused by cerebral palsy have been lifted.

The US FDA has approved an expanded indication for the use of abobotulinumtoxinA (Dysport; Ipsen), now including treatment of pediatric upper and lower limb spasticity including that caused by cerebral palsy (CP).

First approved in 2016 for the treatment of pediatric lower limb spasticity, Ipsen at the time was granted orphan drug exclusivity for lower limb spasticity caused by CP. However, when the FDA approved the drug for treatment of pediatric upper limb spasticity in children age 2 and older in 2019, the indication excluded spasticity caused by CP, as exclusivity for that indication had been awarded to another manufacturer.

The most recent ruling is the result of discussions between the Ipsen, the FDA, and the other manufacturer who selectively waived their exclusivity rights.

“The proactive step to resolve the uncertainty created by the previous CP carveout enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper and lower limb spasticity,” said Sarah Helen Evans, MD, division chief of rehabilitation medicine in the Department of Pediatrics at the Children’s Hospital of Philadelphia, in a statement. “This update ensures patient care, and treating the child as a whole person, can be the focus for physicians and their caregivers when making treatment decisions for both upper and lower limb spasticity.”

Spasticity can occur in conjunction with CP, spinal cord injury, multiple sclerosis, stroke, and brain or head injury, and can include increased muscle tone, muscle contractions, exaggerated deep tendon reflexes, as well as muscle spasms, and can range from mild to severe and uncontrollable spasms.

The injectable drug is currently approved by the FDA for spasticity in patients age 2 and older as well as cervical dystonia in adults. It is contraindicated in patients with a known hypersensitivity to botulinum toxin products, as well as cow’s milk protein. Serious adverse reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. Treatment with Dysport and other botulinum toxin products may cause difficulty with swallowing or breathing as a result of weakened muscles in the area of injection. This risk is especially relevant in those with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders.

The most common adverse events reported in adults with lower limb spasticity are falls, muscular weakness, and pain in extremities, and with upper limb spasticity, muscle weakness. In children with lower limb spasticity, more than 10% of treated patients have reported nasopharyngitis, cough and pyrexia and with upper limb spasticity, upper respiratory tract infection and pharyngitis. In adults with cervical dystonia, at least 5% of treated patients reported muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.

REFERENCE

Ipsen announces updated indication for Dysport® (abobotulinumtoxina) for the treatment of spasticity in children. News release. Ipsen Biopharmaceuticals. July 9, 2020. Accessed July 14, 2020. https://www.businesswire.com/news/home/20200709005981/en/Ipsen-Announces-Updated-Indication-Dysport%C2%AE-abobotulinumtoxinA-Treatment