FDA approves Botox to treat pediatric patients (2 to 17 years of age) with upper limb spasticity

Allergan plc announced that the FDA has approved the company's supplemental biologics application (sBLA) for Boxtox for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity. Botox was granted a six-month Priority Review by the FDA , which is typically granted to therapies that if approved, could offer significant improvements in safety and effectiveness when compared to current standard of care. The FDA is also reviewing an additional sBLA for the use of Botox to treat pediatric patients with lower limb spasticity, with a decision expected in the fourth quarter of this year.

Damage to the brain and spine can result in spasticity, which is often observed as muscle tightness and stiffness in the upper and lower limbs. Upper limb spasticity can interfere with movement at the joints of the upper limb and its severity can range from mild to severe muscle stiffness. Common causes of spasticity in children include cerebral palsy, traumatic brain injury, multiple sclerosis, spinal cord injury, and stroke, which is a group of disorders affecting one's ability to move and maintain balance and posture.

The FDA approval is based on data from two Phase III studies evaluating the safety and efficacy of Botox in over 200 pediatric patients with upper limb spasticity. These trials included a 12-week, double-blind study and a one-year open-label extension study. The approved recommended dose per treatment session is 3 Units per kilogram to 6 Units per kilogram divided among affected muscles of the upper limb. The total dose in pediatric patients should not exceed 8 Units per kilogram body weight or 300 Units, whichever is lower, in a 3-month interval. Treatment with Botox is not meant to replace existing physical therapy or other rehabilitation that may have been prescribed.