The US Food and Drug Administration has approved Allergan’s supplemental biologics application (sBLA) for its BOTOX treatment for paediatric patients with upper limb spasticity.
The FDA granted a six-month priority review to the prescription medicine to treat paediatric patients aged between two and 17 years old.
The agency is reviewing an additional sBLA for the use of BOTOX to treat paediatric patients with lower limb spasticity. A decision on this submission is expected in Q4 2019.
Caused by damage to the brain and spine, spasticity symptoms include muscle stiffness in the upper and lower limbs.
Allergan chief research and development (R&D) officer David Nicholson said: “This FDA approval is special to all of us at Allergan because we can now provide children and their caregivers an advancement in paediatric care with Botox.
“This milestone underscores our constant focus on innovation and builds on our 30-years of research and development efforts with Botox since FDA approval of blepharospasm and strabismus in 1989.”
The agency granted its approval based on data obtained from two Phase III studies that assessed the safety and efficacy of Botox in more than 200 paediatric patients with upper limb spasticity. These trials included a 12-week, double-blind study and a one-year open-label extension study.
Injected into the limbs, BOTOX is used to treat muscle stiffness in children and certain types of eye muscle problems or abnormal spasm of the eyelids in people 12 years and older.