FDA approves expanded BOTOX® (onabotulinumtoxinA) label for the treatment of Pediatric patients with spasticity

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 motion at a joint affected by a fixed contracture.

Spasticity is a debilitating neurological condition involving muscle stiffness that can result in tight muscles in the upper and lower limbs. The severity can range from mild to severe, often interfering with normal muscular movement and function. This can result in delayed or impaired motor development, as well as difficulty with posture and positioning. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke.

“Cerebral palsy is the most common cause of pediatric spasticity, which can have a profound impact on a child’s development and quality of life. With its established safety and efficacy profile, we are pleased that BOTOX^® can now more broadly support physicians treating pediatric spasticity,” said Mitchell F. Brin, M.D., Senior Vice President, Chief Scientific Officer, BOTOX^® & Neurotoxins, AbbVie. “Building upon our 30 years of research and development efforts with BOTOX^®, our commitment to neurotoxin innovation continues, and it is particularly rewarding to bring forth new treatments to advance care for pediatric patients.”

The safety and efficacy of BOTOX^® as treatment for lower limb spasticity for pediatric patients is supported by a Phase 3 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.

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