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.
Product type:
Summary of Cancellation for Panzyga
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation
2019-11-27
What was the purpose of this submission?
The purpose of this submission was to seek approval to add a new indication for "The treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP)."
What did the company submit to support its submission?
The sponsor submitted labelling and clinical components. The clinical safety and efficacy information consisted of the following: a pivotal Phase 3b trial (Study IS-II-CA-02), a Post-marketing surveillance study (GAM10-06), and a retrospective chart review on CIDP patients treated with Panzyga after switch from another IVIG product (study RDC-II-CA-01).
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
At the time of the cancellation, the review of the submission was nearing completion. Health Canada had identified some deficiencies in the data that would have precluded issuing an approval. The sponsor chose to cancel their submission without prejudice to refiling.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials.
Additional information
*Proposed Brand Name:
Panzyga