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: the treatment of adults with cervical dystonia; a new strength (500 Unit vial) is also added.
Why was the decision issued?
The pivotal study submitted demonstrated that Dysport was statistically significantly more effective than placebo in reduction of the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) Total Score in subjects with cervical dystonia four weeks after the treatment. The effect produced lasts several months and injections need to be repeated periodically. The results from the other studies (that is, dose finding and repeated dose studies) provided supportive evidence for the treatment.
In conclusion, Dysport was shown to provide temporary relief for cervical dystonia, a condition for which the available treatment has limited efficacy and potential significant side effects. Dysport was generally well tolerated, and all the safety concerns are adequately captured in the product monograph.
Overall, the benefits of Dysport outweigh the risks in the treatment in subjects with cervical dystonia.
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 |