Regulatory Decision Summary for Ultomiris
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:
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Type of submission:
Control number:
What was the purpose of this submission?
The purpose of this submission was to seek market authorization of a new 100 mg/mL drug product strength of ravulizumab in two vial presentations, 300 mg/3 mL and 1,100 mg/11 mL. Ravulizumab is currently authorized as a 10 mg/mL strength in a 30 mg/3 mL vial presentation.
Why was the decision issued?
In this Supplement to a New Drug Submission (SNDS), no changes to the currently authorized indication or currently authorized body weight-based posology were sought, only the authorization of the new 100 mg/mL formulation. Compared with the 10 mg/mL drug product strength, the 100 mg/mL strength is easier to dilute (i.e. less vials required) and can be administered faster to the patients.
The clinical data provided suggest no changes in terms of efficacy, ravulizumab exposure, safety, or immunogenicity when ravulizumab was dosed using the new 100 mg/mL strength relative to the currently authorized 10 mg/mL strength.
The benefit/risk profile of ravulizumab remains favourable for all the indications for which this product is authorized.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ULTOMIRIS | 02533456 | ALEXION PHARMA GMBH | RAVULIZUMAB 1100 MG / 11 ML |
| ULTOMIRIS | 02533448 | ALEXION PHARMA GMBH | RAVULIZUMAB 300 MG / 3 ML |