Regulatory Decision Summary for IDELVION
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?
This New Drug Submission (NDS) was submitted to seek market authorisation for use of Idelvion (rIX-FP) in the treatment and prophylaxis of bleeding in subjects of all ages suffering with severe congenital FIX deficiency.
Proposed and Recommended Indication(s):
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes;
- Control and prevention of bleeding episodes;
- Control and prevention of bleeding in the perioperative setting.
Why was the decision issued?
The benefit conferred by rIX-FP as compared with other FIX products is the potential for a greatly improved quality of life resulting from reduced dose frequency and possible reduction in the total annual dose required for equal effect. For pediatric subjects especially, these two factors are of major importance.
The benefit is unaccompanied by any identified downside in terms of side effects or ease of product use. In these regards it appears to be no different from other products and may even be an improvement by reducing thrombotic risk. At present the important residual questions are addressed in the RMP.
There is a post-marketing commitment to complete and report on the outcomes of two ongoing phase III studies.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
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 |
|---|---|---|---|
| IDELVION | 02451352 | CSL BEHRING CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 1000 UNIT / VIAL |
| IDELVION | 02451360 | CSL BEHRING CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 2000 UNIT / VIAL |
| IDELVION | 02451336 | CSL BEHRING CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 250 UNIT / VIAL |
| IDELVION | 02451344 | CSL BEHRING CANADA INC | COAGULATION FACTOR IX (RECOMBINANT), ALBUMIN FUSION PROTEIN (RIX-FP) 500 UNIT / VIAL |