Regulatory Decision Summary for Berinert 500/ Berinert 1500
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.
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What was the purpose of this submission?
Berinert (C1-esterase inhibitor) is indicated for the treatment of acute abdominal, facial, or laryngeal attacks of hereditary angioedema (HAE) of moderate to severe intensity.
The purpose of this submission is to extend the existing indication to the pediatric age group by submitting data from post-marketing studies, as well as referencing of published data, and to update the Geriatric section of the Product Monograph (PM).
Why was the decision issued?
The expanded indication and label revisions proposed are based on safety data collected and presented in study CE1145_5002 (Berinert Registry) and CE1145_4001 (Berinert Antibody Study) as well as detailed information from the published literature regarding use of Berinert to treat children with hereditary angioedema (HAE).
The study results show that the rates of adverse events in subjects younger than 12 years and in adolescents were lower than in the older age groups though they received a higher median dose of Berinert.
The results of long-term observation in the Registry supported the favorable safety profile of Berinert when administered in a broad population of subjects with ages ranging from 5 to 83 years of age. This favorable safety profile was observed when Berinert was administered at home or in a healthcare setting either as prophylaxis or acute therapy.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations