FDA Approves Expanded Use for BOTOX

Allergan and AbbVie received approval from the U.S. FDA for its supplemental Biologics License Application (sBLA) for 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.

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.