21 June 2019 - Approval marks 10th Botox therapeutic indication in its 30th anniversary year.

Allergan today announced that the U.S. FDA approved the company's supplemental biologics application (sBLA) for Botox for the treatment of paediatric 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 paediatric patients with lower limb spasticity, with a decision expected in the fourth quarter of this year.

The FDA approval is based on data from two Phase 3 studies evaluating the safety and efficacy of Botox in over 200 paediatric patients with upper limb spasticity. These trials included a 12-week, double-blind study and a one-year open-label extension study.

Read Allergan press release