FDA Approves Tenecteplase for Acute Ischemic Stroke

The US Food and Drug Administration has approved the thrombolytic tenecteplase for the treatment of patients with acute ischemic stroke, manufacturer Genentech announced today.

The approval is based on the 1,600-patient AcT trial that showed tenecteplase resulted in comparable rates of neurologic function when compared with alteplase (Activase; Genentech).

In AcT, which included adults presenting within 4.5 hours of symptom onset, there was no significant difference in the percentage of patients with a modified Rankin scale score of 0-1 at 90 to 120 days with tenecteplase versus alteplase, researchers reported in the Lancet in 2022. Likewise, rates of intracerebral hemorrhage at 24 hours were similar between both treatment arms.

Comparable outcomes between the two agents were also observed in the TRACE-2 study, conducted in China.

Tenecteplase, a tissue plasminogen activator, is delivered as a 5- to 10-second intravenous bolus, whereas alteplase requires an hour-long infusion. Alteplase was first approved by the FDA in 1996 for acute ischemic stroke, making tenecteplase just the second medication approved for the condition in nearly 30 years.

Tenecteplase is also approved as a thrombolytic agent for patients presenting with acute MI. Recent studies have explored the potential for tissue plasminogen activators to be used in tandem with stroke thrombectomy to enhance distal reperfusion and neurologic outcomes.