FDA approves sBLA for Botox in pediatric patients with lower limb spasticity caused by cerebral palsy.- Allergan/AbbVie

Allergan announced that the FDA has approved a supplemental Biologics License Application (sBLA) that supports expanded use of Botox (onabotulinumtoxin A) for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy. This label expansion is based on Allergan and another manufacturer selectively waiving orphan exclusivity marketing rights each company held for the use of their respective neurotoxins in the treatment of pediatric patients with spasticity caused by cerebral palsy. Botox was first approved in June 2019 for the treatment of pediatric patients with upper limb spasticity and in October 2019 for the treatment of pediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy. Botox has not been shown to improve upper extremity functional abilities, or range of motion at a joint affected by a fixed contracture. The safety and efficacy of Botox as treatment for lower limb spasticity for pediatric patients is supported by a Phase III study with more than 300 patients two to 17 years of age with lower limb spasticity because of cerebral palsy. These trials included a 12-week, double-blind study and a one-year open-label extension study.