Regulatory Decision Summary for Cutaquig
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.
Type of submission:
What was the purpose of this submission?
The purpose of this submission is to obtain marketing authorization for the following indications: primary immunodeficiency syndromes (PID) and secondary immunodeficiency syndromes (SID). Treatment with subcutaneous immunoglobulin (SCIG) at doses between 0.1-0.2g / kg of weight every week enhances serum levels of IgG well above 5-6 g/L, which are the minimum values regarded as suitable for avoiding infections in immunodeficient patients.
Why was the decision issued?
The efficacy, safety and tolerability of Cutaquig have been assessed in a phase III clinical study in subjects with primary immunodeficiency syndromes.
The benefits of Cutaquig in patients with primary humoral immunodeficiency are similar to those of intravenous immunoglobulin (IVIG), given the fact that dosing is based upon matching bioavailability with previous IVIG product use. In addition, because of subcutaneous administration, there is the potential advantage of home use, or use in patients who cannot tolerate IVIG. The risks of local reactions are greater for Cutaquig than for IVIG, but systemic reactions may be less frequent. The most common types of infusion site reactions were redness, swelling and pruritus. However, there have not been head-to-head comparisons between Cutaquig and an IGIV product for safety.
Overall, the risks of Cutaquig as compared to its benefits in the immunodeficiency patients are acceptable.
To conclude, the risk-benefit assessment of Cutaquig is favorable and similar to other marketed SCIG products.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
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