FDA approves sBLA for Botox to treat pediatric patients (2 to 17 years of age) with lower limb spasticity.-Allergan/AbbVie

Allergan plc announced that the FDA approved the company's supplemental Biologics License Application (sBLA) for Botox for the treatment of pediatric patients (2 to 17 years of age) with lower limb spasticity, excluding spasticity caused by cerebral palsy (CP).

This marks the 11th Botox therapeutic indication, having been approved for pediatric upper limb spasticity (ULS) earlier this year. 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 severity can range from mild to severe muscle stiffness.

The FDA approval is based on a Phase III study evaluating the safety and efficacy of Botox in more than 300 pediatric patients aged two to 17 years old 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 another company. These trials included a 12-week, double-blind study and a one-year open-label extension study.