FDA Approves BOTOX for Pediatric Patients with Lower Limb Spasticity

Allergan plc announced that the U.S. Food and Drug Administration (FDA) approved the company’s supplemental Biologics License Application (sBLA) for BOTOX for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP). This marks the 11th 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. “This milestone will continue to support and advance care for children and their caregivers who may be struggling with lower limb spasticity. Here at Allergan, we look forward to continuing to highlight our unwavering attention to innovation and build on our 30-years of research and development efforts with BOTOX since FDA approval of blepharospasm and strabismus in 1989.”

The FDA approval is based on a Phase 3 study evaluating the safety and efficacy of BOTOX in more than 300 pediatric patients aged two to 17 years old being treated for lower limb spasticity. 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.

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.

“Pediatric lower limb spasticity inhibits normal muscular movement and function and can result in delayed or impaired motor development, as well as difficulty with posture and positioning,” said Mark Gormley, Jr. M.D., Pediatric Rehabilitation Medicine Specialist, Gillette Children’s Specialty Healthcare-St. Paul. “BOTOX has a well-established safety and efficacy profile, and supports children and adolescents successfully manage both their upper and lower limb spasticity.”

Allergan is committed to providing resources and services, such as the BOTOX Savings Program, to help ensure BOTOX is accessible and affordable to patients.

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