The US Food and Drug Administration (FDA) has approved Allergan’s supplemental biologics application (sBLA) for BOTOX (onabotulinumtoxinA) 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, Allergan announces in a media release.
“Watching a child suffering with any degree of upper limb spasticity is very difficult,” says David Nicholson, chief research and development officer, Allergan. “This FDA approval is special to all of us at Allergan because we can now provide children and their caregivers an advancement in pediatric care with BOTOX. We also look forward to the FDA’s decision on pediatric lower limb spasticity and continuing to serve our patients globally.”
The FDA approval is based on data from two Phase 3 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, the release adds.
[Source(s): Allergan, PR Newswire]