Allergan said Thursday that the U.S. FDA approved its supplemental Biologics License Application (sBLA) for Botox for the treatment younger patients with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP).
Allergan noted that this marks the eleventh Botox therapeutic indication, having been approved for pediatric upper limb spasticity (ULS) earlier this year. Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs, and can interfere with movement. The severity can range from mild to severe muscle stiffness.
“Lower limb spasticity can impact many aspects of a child’s life and have a drastic influence on their overall development and quality of life,” said David Nicholson, Chief Research and Development Officer, Allergan.
The FDA approval is based on a Phase 3 study testing Botox in more than 300 patients aged two to 17, being treated for lower limb spasticity.
Allergan said that, while trial participants had cerebral palsy, the approved indication excludes lower limb spasticity caused by cerebral palsy due to marketing exclusivity by another company. These trials included a 12-week, double-blind study and a one-year open-label extension study, Allergan noted.
The approved recommended dose per treatment session is 4 Units per kilogram to 8 Units per kilogram divided among affected muscles of the lower limb. The total dose per treatment session in the lower limb should not exceed 8 Units per kilogram or 300 Units, whichever is lower. When treating both lower limbs or upper and lower limbs in combination, the total dose in pediatric patients should not exceed 10 Units per kilogram body weight or 340 Units, whichever is lower, in a 3-month interval.
Mark Gormley, a Pediatric Rehabilitation Medicine Specialist at Gillette Children’s Specialty Healthcare-St. Paul said that Botox has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity.