Regulatory Decision Summary for ZINBRYTA
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?
The purpose of this NDS was to seek authorization for marketing of ZINBRYTA for the treatment of relapsing forms of multiple sclerosis (MS).
Why was the decision issued?
The efficacy and safety of ZINBRYTA were assessed in two randomized, double-blind, controlled studies. The efficacy results obtained from these two clinical trials demonstrated a reduction of annualized relapse rate (ARR) in comparison to both placebo and to AVONEX (an interferon beta-1a product).
ZINBRYTA is supplied in a single-dose prefilled syringe or a single dose-prefilled pen. The recommended dosage of ZINBRYTA is 150 milligrams to be injected subcutaneously once a month.
The results from safety studies showed that ZINBRYTA can cause serious and life threatening liver injury (liver failure and autoimmune hepatitis) and immune-mediated disorders (skin reactions, lymphadenopathy, non-infectious colitis, etc.). Other adverse events reported more commonly in patients treated with ZINBYRTA than comparators (placebo or AVONEX) included: serious infections, acute hypersensitivity, seizures, and depression. In order to mitigate these reported safety issues, Health Canada required several risk management measures which included (but were not limited to): the restricted conditions of use of ZINBRYTA as specified in the Canadian Product Monograph, its discontinuation if liver abnormalities occur, etc. In addition, ZINBRYTA will only be available under a Controlled Distribution Program.
Taking into account the above, the benefit/risk ratio is considered favorable. However, in order to ensure that this benefit continues to outweigh risk after authorization, Health Canada has required several post-approval activities and an updated Risk Management Plan.
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 |
|---|---|---|---|
| ZINBRYTA | 02459620 | BIOGEN CANADA INC | DACLIZUMAB BETA 150 MG / ML |