Regulatory Decision Summary for NIASTASE RT
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?
NiaStase RT is currently authorized for marketing in Canada for the following indications:
- In hemophilia A/B patients with inhibitors to FVIII or FIX, respectively, for the treatment of bleeding episodes (including treatment and prevention of those occurring during and after surgery).
- For the treatment of severe bleeding episodes and the prevention of bleeding in surgical interventions or invasive procedures in Glanzmann’s thrombasthenia with clinical refractoriness and/or platelet-specific antibodies, or where platelets are not immediately available.
Purpose of the submission
| The purpose of this SNDS is to seek the marketing authorization of NiaStase RT for an additional indication: ‘In patients with acquired hemophilia for the treatment of bleeding episodes, and for the prevention of bleeding in those undergoing surgery or invasive procedures’. |
Proposed and Recommended Indication(s):
The proposed indication is: ‘For the treatment of bleeding episodes and prevention of bleeding in those undergoing surgery or invasive procedures in patients with acquired hemophilia’
The recommended indication is: ‘In adult patients with acquired hemophilia, for the treatment of bleeding episodes, and for the prevention of bleeding in those undergoing surgery or invasive procedures.
The recommended dosage is 90 μg/kg
Why was the decision issued?
Given the rarity of acquired hemophilia and the available treatment options for the treatment of this disease, it has been determined that the risk benefit profile of Niastase RT is considered favourable in adult patients with acquired hemophilia for the treatment of bleeding episodes, and for the prevention of bleeding in those undergoing surgery or invasive procedures.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.