Regulatory Decision Summary for Dysport Therapeutic

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

abobotulinumtoxinA

Therapeutic area:

M03AX01 BOTULINUM TOXIN

Type of submission:

Supplemental New Drug Submission

Control number:

202245
What was the purpose of this submission?

 

Dysport Therapeutic is currently indicated to reduce the subjective symptoms and objective signs of cervical dystonia in adults and for the symptomatic treatment of focal spasticity affecting the upper limbs in adults.

The intent of this submission is to add the indication for the treatment of lower limb spasticity in pediatric patients 2 years of age and older.

 

Why was the decision issued?

 

Dysport Therapeutic was shown to provide temporary relief of lower limbs spasticity in paediatric subjects due to cerebral palsy (CP) in one pivotal and two supportive clinical studies. The clinical benefits observed after a single treatment was sustained with repeated dose treatments. The therapeutic goal of management of children with focal limb spasticity is to intervene early to improve comfort/function and to limit or delay the consequences of spasticity on bone growth.

Dysport Therapeutic is generally well tolerated at the recommended doses. The majority of the adverse events reported were mild to moderate in intensity, reversible and none were serious. The potential risks are addressed in the product monograph.

Dysport Therapeutic has demonstrated a favorable benefit to risk profile for the treatment of lower limb spasticity in paediatric patients 2 years of age and older.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.