The US Food and Drug Administration (FDA) has expanded the approval of Allergan’s Botox (onabotulinumtoxinA) to cover the treatment of paediatric patients with upper limb spasticity.
The latest FDA approval for Botox is for patients aged between two and 17 years whose movement at the joints of the upper limb is restricted due to their condition with the severity ranging from mild to severe muscle stiffness.
It was given following a six-month priority review by the regulator, which is given typically to therapies that if approved, could provide considerable improvements in safety and effectiveness when compared to current standard of care.
The neuromodulator secured its first FDA approval for the treatment of upper limb spasticity, or increased muscle stiffness in the elbow, fingers and wrist in adults, in 2010.
The paediatric approval for the indication was granted by the regulator based on the findings of two phase 3 trials studying the safety and efficacy of Botox in more than 200 paediatric patients with upper limb spasticity. The late-stage trials included a 12-week, double-blind study and an open-label extension study carried out for 12 months.
According to Allergan, the approved recommended dose per treatment session is 3-6 units per kg split among affected muscles of the upper limb. The total dose in paediatric patients should not be over eight units per kg body weight or 300 units, whichever is lower, in a three-month interval, said the company.
Allergan chief research and development officer David Nicholson said: “Watching a child suffering with any degree of upper limb spasticity is very difficult. 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.
“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.”
An additional supplemental biologics application (sBLA) for Botox is being reviewed by the FDA for the treatment of paediatric patients with lower limb spasticity. A decision from the regulator is likely to be announced in the fourth quarter of 2019.