The Food and Drug Administration (FDA) has expanded the indication of Dysport (abobotulinumtoxinA; Ipsen) to include the treatment of upper limb spasticity in patients aged 2 years and older, excluding spasticity caused by cerebral palsy. Previously, Dysport was only approved to treat lower limb spasticity in patients aged 2 years and older.
The approval was based on data from a double-blind, low-dose controlled, multicenter, phase 3 study that evaluated the efficacy and safety of Dysport in 210 patients aged 2 to 17 years for upper limb spasticity. Patients were randomized 1:1:1 to receive Dysport 16 Units/kg, 8 Units/kg, or 2 Units/kg for 6 weeks. The primary end point was the mean change from baseline in the primary targeted muscle group (elbow or wrist flexors) on Modified Ashworth Scale (MAS), which measures the amount of muscle tone using a 6-point scale; secondary end points included the mean Physician’s Global Assessment (PGA) score of treatment response and mean Goal Attainment Scale (GAS) score.
Results demonstrated statistically significant improvements to the primary targeted muscle group from baseline in MAS at Week 6 for Dysport 16 Units/kg (-2.3; P <.0001) and 8 Units/kg (-2.0; P =.0118) compared with Dysport 2 Units/kg (-1.6). A statistically significant difference was not observed in the mean PGA or GAS scores despite favorable results for higher dose Dysport. A majority of patients in the clinical study were retreated between 16-28 weeks; however, some patients had a longer duration of response (ie, 34 weeks or more).
With regards to safety, the most common treatment-emergent adverse reactions were upper respiratory tract infection and pharyngitis. Dysport and all botulinum toxin products carry a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism.
“For physicians, it is reassuring to have a botulinum toxin treatment in Dysport which demonstrated sustained symptom relief for spasticity, which can be physically challenging for children,” said Ann Tilton, MD, study investigator and Professor of Clinical Neurology at the Louisiana State University Health Sciences Center New Orleans. “This FDA decision for Dysport means we now have an approved therapy to offer children and adolescents seeking improvements in mobility in both upper and lower limbs.”
Dysport is also indicated for the treatment of cervical dystonia and spasticity in adults. The product is available as 300 Unit and 500 Unit single-dose vials.
For more information visit ipsen.com.