Regulatory Decision Summary for DYSPORT
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
Dysport is currently indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adult. The purpose of this submission is to add an additional indication: for the systematic treatment of focal spasticity affecting upper limbs in adults; a new strength (500 Unit vial) is also added.
Why was the decision issued?
The efficacy was demonstrated in a pivotal study that showed that Dysport (at doses of 500 and 1,000 Units) was statistically significantly more effective than placebo in reducing arm spasticity four weeks after the treatment. The results from the other studies (that is, dose finding and repeated dose studies) provided supportive evidence for the treatment. The effect produced lasts over a period of months and injections need to be repeated periodically.
In conclusion, Dysport was shown to provide temporary relief for upper limbs spasticity, a condition for which the available treatment has limited efficacy and potential significant side effects. Dysport is generally well tolerated, and all safety concerns are adequately captured in the product monograph.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| DYSPORT THERAPEUTIC | 02456117 | IPSEN BIOPHARMACEUTICALS CANADA INC | ABOBOTULINUMTOXINA 500 UNIT / VIAL |
| DYSPORT AESTHETIC | 02387735 | IPSEN BIOPHARMACEUTICALS CANADA INC | ABOBOTULINUMTOXINA 300 UNIT / VIAL |