July 9, 2020
The U.S. FDA has approved an expanded indication for Dysport® (abobotulinumtoxinA) intramuscular injection, manufactured by Ipsen Biopharmaceuticals. The drug is now indicated to treat spasticity in patients who are at least two years of age, regardless of whether it occurs in the upper or lower limbs and is caused by cerebral palsy (CP). Previously, Dysport could not be used to treat upper limb spasticity caused by CP.
Spasticity is an abnormal increase in muscle stiffness or tone, which can lead to motor impairment. It is usually caused by nerve damage, such as that caused by cerebral palsy, multiple sclerosis, stroke, spinal cord damage, and brain or head trauma. The condition can range from mild to severe, with symptoms that include rapid muscle contraction and severe, painful muscle spasms.
The initial exclusion of upper limb spasticity caused by CP from Dysport’s approved use was due to orphan drug exclusivity rights granted to Allergan, the manufacturer of Botox. Ipsen worked with the FDA and Allergan to selectively waive these rights to support better access to care for patients. Ipsen also waived its own exclusivity rights for the treatment of lower limb spasticity caused by CP.
Recommended dosing under the spasticity indication is based on individual patient factors that include the patient’s age, muscles affected, severity of spasticity, and treatment and adverse reaction history with botulinum toxins. Dysport is administered via intramuscular injection by a healthcare professional.
A black box warning cautions that there is a risk of distant spread of effects with all botulinum products, including Dysport. The effects may spread from the area of injection and produce symptoms consistent with botulinum toxin hours to weeks after injection. This can cause life-threatening difficulties with swallowing and breathing. The risk is believed to be greatest in children treated for spasticity, though adults may experience symptoms as well.
First FDA approved in 2009, Dysport is also indicated to treat cervical dystonia in adults as well as lower limb spasticity in patients who are at least two years of age. In addition, Dysport has a cosmetic indication to provide temporary improvement in the appearance of moderate to severe glabellar lines (forehead frown lines) associated with procerus and corrugator muscle activity in adults at least 65 years of age.