Regulatory Decision Summary for OCREVUS
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?
The purpose of this New Drug Submission (NDS) was to seek authorization for marketing of Ocrevus for the treatment of relapsing forms of multiple sclerosis (MS).
Why was the decision issued?
The efficacy of Ocrevus was assessed in two randomized, double-blind, double-dummy, active comparator-controlled clinical trials with identical designs.
The efficacy results obtained from these two clinical trials demonstrated a reduction of annualized relapse rate (ARR) in comparison to REBIF (an interferon beta-1a product) in patients with relapsing remitting multiple sclerosis (RRMS). Other benefits of Ocrevus over REBIF were also observed on disability progression, and brain MRI (magnetic resonance imaging) measures.
The results from safety studies showed that Ocrevus can cause serious Infusion Related Reactions (IRRs), as well as increase the risk of infections/opportunistic infections and breast cancer. Other safety concerns include depression, cardiovascular events, hepatic/biliary/pancreatic events, neutropenia, and decrease in serum immunoglobulins. 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 Ocrevus as specified in the Canadian Product Monograph.
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 the sponsor to complete several post-approval activities and an updated Risk Management Plan.
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 |
|---|---|---|---|
| OCREVUS | 02467224 | HOFFMANN-LA ROCHE LIMITED | OCRELIZUMAB 30 MG / ML |