FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., July 9, 2020 /PRNewswire/ -- Allergan, an AbbVie (NYSE: ABBV) company, today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of BOTOX® 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 mo
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