Regulatory Decision Summary for Panzyga
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 submission is to seek approval to add the indication of Panzyga in the treatment of patients with moderate to severe Guillain-Barré Syndrome (GBS).
Why was the decision issued?
GBS is an acute polyneuropathy that typically presents as a mild parasthesia and a progressive weakness. An ascending paralysis is frequently observed involving the limbs and bulbar muscles. Progressive weakness either plateaus or improves in 90% of the cases. On examination, there is evidence of nerve conduction slowing or blockade in most patients.
Current treatment guidelines recognize Plasma Exchange (PEX) and Immune Globulin Intravenous (IVIG) as equally efficacious agents for the treatment of GBS. Both agents are clinically proven to hasten the time to recovery and improve disability scores when administered within the early stages of disease progression.
According to a Cochrane systematic review, moderate-quality evidence shows that patients treated within two weeks from onset of symptoms with IVIG had recovery as much as PEX. This review also found that patients treated with IVIG tended to have fewer adverse events, fewer treatment complications, and were less likely to discontinue therapy as compared with PEX.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.