Regulatory Decision Summary for Tnkase

This Supplement was filed for Tnkase (Tenecteplase) for intravenous use in adults for the treatment of acute ischemic stroke (AIS), when initiated within 0 to 4.5 hours of symptom onset. The submission is supported by evidence from the AcT Study, a Phase III, investigator-initiated, randomized trial designed to evaluate the non-inferiority of tenecteplase compared with alteplase in this patient population. Conducted independently by the University of Calgary and funded by the Canadian Institute of Health Research, the study demonstrated that tenecteplase is a non-inferior and clinically meaningful alternative to alteplase. The sponsor was not involved in the design or conduct of the trial but performed independent analyses of the locked study database to support this Supplement to a New Drug Submission (SNDS).

Data provided in this submission demonstrated that tenecteplase 0.25 mg/kg is non-inferior to alteplase 0.9 mg/kg for treating acute ischemic stroke within 4.5 hours of symptom onset. The safety profile was comparable between treatments, with similar rates of symptomatic intracerebral hemorrhage, mortality, and other adverse events. Considering the totality of clinical evidence and the established safety experience of tenecteplase in myocardial infarction, the benefit-risk profile supports its approval as a non-inferior and safe alternative to alteplase for intravenous thrombolysis in acute ischemic stroke.

The quality and manufacturing information submitted for the TNKase 25 mg/vial presentation has demonstrated that the Drug Product can be consistently manufactured to meet the approved specifications.

The chemistry and manufacturing information submitted for Tnkase has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

Overall, the benefit-harm-uncertainty profile was favourable for Tnkase for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.

For further details about Tnkase, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.