Allergan announced that the FDA has approved its supplemental biologics application for Botox, or onabotulinumtoxinA, for the treatment of patients aged 2 to 17 years with upper limb spasticity.
The approval, which comes after a 6-month priority review by the FDA, was based on data from two phase 3 studies — a 12-week, double-blind study and a 1-year open-label extension study — that evaluated the safety and efficacy of Botox in more than 200 pediatric patients with upper limb spasticity.
"Pediatric upper limb spasticity is a significant concern and can negatively impact a child's development and quality of life," Mark Gormley Jr., MD, pediatric rehabilitation medicine specialist at Gillette Children's Specialty Healthcare, St. Paul, said in an Allergan press release. "Because spasticity is particularly debilitating to growing children, it requires ongoing care. Botox has a well-established safety and efficacy profile, and I believe it will be an important treatment option in helping successfully manage upper limb spasticity in children and adolescents."
According to the release, the approved recommended dose per treatment session is 3 U/kg to 6 U/kg divided among affected muscles of the upper limb. The total dose in pediatric patients should not exceed 8 U/kg of body weight or 300 U total, whichever is lower, in a 3-month interval.
The FDA is also reviewing Botox as a treatment option for pediatric patients with lower limb spasticity. A decision is expected in the fourth quarter of 2019, according to the release.
In related news, AbbVie announced today that it will acquire Allergan for about $63 billion in cash and stock.
Disclosure: Infectious Disease s in Children was unable to confirm relevant financial disclosures at time of publication.