Regulatory Decision Summary for Vyncro / Canakinumab

Decision issued

The sponsor, Novartis Pharmaceuticals Canada, Inc., cancelled the submission before a final decision was issued by Health Canada.

Date of cancellation

December 11, 2018

What was the purpose of this submission?

The sponsor filed an NDS to obtain authorization for canakinumab Novartis (150 mg canakinumab solution for subcutaneous injection via pre-filled syringe or pre-filled pen/auto-injector) for the reduction of the risk of cardiovascular death and non-fatal coronary syndrome in patients with prior myocardial infarction and serum high sensitivity C-Reactive Protein (hsCRP) ≥ 2 mg/L at treatment initiation.

What did the company submit to support its submission?

The sponsor submitted drug quality, clinical, and labelling components.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

Health Canadas review of the submission was ongoing at the time of cancellation. The assessment had identified issues with the clinical evidence provided to support the proposed indication for canakinumab Novartis. These issues were not resolved at the time of cancellation.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

Canakinumab Novartis is not currently authorized in any international jurisdiction for cardiovascular risk reduction; however, canakinumab is currently authorized for sale in Canada as ILARIS. No consequences to patients accessing canakinumab under the SAP or via non-cardiovascular clinical trials are expected as a result of the cancellation of this submission.

Additional information

Proposed Brand Name:

Canakinumab Novartis