FDA Approval of Dysport® for injection for the treatment of Lower Limb Spasticity in children aged two and older
On 1st August 2016 the U.S. Food and Drug Administration (FDA) has approved Dysport® (abobotulinumtoxinA) for injection for the treatment of pediatric lower limb (PLL) spasticity in children two years of age and older. Dysport® is the First and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity.
A condition in which there is an abnormal increase in muscle tone or stiffness
Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement. Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and may occur in association with cerebral palsy, spinal cord injury, multiple sclerosis, stroke, and brain or head trauma.
Lower limb spasticity commonly involves spasticity in the gastrocnemius and soleus muscle complex located in the calf. These calf muscles are the chief extensors of the foot at the ankle-joint. In walking, they work to raise the heel from the ground.
Symptoms of spasticity may include increased muscle tone, rapid muscle contractions, exaggerated deep tendon reflexes, and/or muscle spasms. The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.
A condition that greatly impacts children and their caregivers
“This approval in the US is a milestone in the treatment of pediatric lower limb spasticity, a condition that greatly impacts both children two years of age and older living with this form of spasticity and their caregivers. Dysport® is the first and only botulinum toxin approved by the FDA for this indication,” said Claude Bertrand, Executive Vice President, Research and Development, Chief Scientific Officer, Ipsen.
“The approval of abobotulinumtoxinA means that, for the first time in the USA, physicians have an FDA-approved botulinum toxin and recommended dosing and administration guidance for the treatment of children from two years of age and older with lower limb spasticity,” said Mauricio R. Delgado M.D., Professor of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center and the U.S. principal investigator of the Phase III trial.
Dysport® is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A. It is supplied as a lyophilized powder. Dysport® has approved therapeutic indications in the United States for the treatment of adults with Cervical Dystonia (CD), the treatment of Upper Limb Spasticity (ULS) in adult patients, and now in the treatment of lower limb spasticity in children to improve tone and spasticity. The medicine was first registered in the United Kingdom in 1990 for other uses and is licensed in more than 80 countries in eight different indications, with over 1,300 peer-reviewed publications.