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# Allergan sBLA Approved for Pediatric Spasticity
- URL: https://www.fdaweb.com/allergan-sbla-approved-for-pediatric-spasticity/
- Published: 2019-10-24T12:00:00.000Z
- Updated: 2026-09-15T01:58:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145331

FDA has approved an Allergan supplemental BLA for Botox in treating pediatric patients (two to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy. 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 company says. Approval is based on data from a Phase 3 study evaluating the safety and efficacy of Botox in more than 300 pediatric patients 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,” the company says.