The US Food and Drug Administration (FDA) has approved tenecteplase for the treatment of acute ischemic stroke, marking a major advancement in thrombolytic therapy. This makes tenecteplase only the second FDA-approved medication for the condition in nearly 30 years, following alteplase, which was approved in 1996.
Tenecteplase, a tissue plasminogen activator, has a significant administration advantage, it is delivered via a single 5-second intravenous bolus, compared to alteplase’s standard 60-minute infusion. This streamlined administration may enable faster and more efficient treatment in emergency stroke care.
The FDA approval was based on the AcT randomized controlled trial, which demonstrated noninferiority of tenecteplase to alteplase in stroke patients treated within 4.5 hours of symptom onset. The study showed similar functional recovery rates, with 40% of tenecteplase patients and 35% of alteplase patients achieving a modified Rankin score of 0-1 at 90-120 days. Safety outcomes were comparable, with no significant difference in intracerebral hemorrhage or 90-day mortality between the two drugs.
Genentech has announced plans to introduce a new 25-mg vial configuration in the coming months to support the expanded use of TNKase for stroke.
For stroke specialists and emergency physicians, this approval introduces a promising alternative thrombolytic therapy that may simplify and improve acute stroke management.
