Botox gets FDA approval for children with limb spasticity
Allergan has received FDA approval for Botox to treat paediatric patients with lower limb spasticity.
OnabotulinumtoxinA has been approved for paediatric patients of two to 17 years of age, though it has not been approved to treat spasticity of muscles caused by cerebral palsy.
Botox received FDA approval for upper limb spasticity in paediatric patients earlier this year.
This marks the 11th approved therapeutic indication for Botox. It is based on a phase 3 study of more than 300 paediatric patients. Trials included a 12-week, double blind study and a one-year open extension study.
Cerebral Palsy patients with lower limb spasticity were included in the study, however another company has marketing rights for a drug used to treat this specific indication.
Spasticity is a neurological condition that causes muscle stiffness and can interfere with movement. The severity can range from mild to severe.
"Lower limb spasticity can impact many aspects of a child's life and have a drastic influence on their overall development and quality of life," said David Nicholson, chief research and development officer at Allergan.
"This milestone will continue to support and advance care for children and their caregivers who may be struggling with lower limb spasticity.
“…We look forward to continuing to highlight our unwavering attention to innovation and build on our 30 years of research and development efforts with Botox since FDA approval of blepharospasm and strabismus in 1989."