Allergan announced that the U.S. FDA has approved the company's supplemental Biologics License Application for Botox for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy.
This marks the 11th Botox therapeutic indication. 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 FDA approval is based on 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 Ipsen Biopharmaceuticals, who got the approval for Dysport injections in 2016.
Read the press release
