The US Food and Drug Administration (FDA) has approved the thrombolytic tenecteplase (TNKase, Genentech) for treatment of acute ischemic stroke in adults.
The drug is administered as a single, 5-second intravenous bolus — a faster and simpler administration compared to the standard of care 60-minute infusion of alteplase (Activase; Genentech), the manufacturer said in a news release.
The company noted that it will introduce a new 25-mg vial configuration in the coming months to support the approval of TNKase in acute ischemic stroke.
Stroke is the fifth leading cause of death and the leading cause of long-term disability in the US, affecting more than 795,000 people each year.
The approval of TNKase for acute ischemic stroke was based on results of the AcT (Alteplase Compared to Tenecteplase) randomized controlled trial, which showed that tenecteplase was noninferior to alteplase in treating patients with acute ischemic stroke within 4.5 hours of symptom onset.
The data showed that roughly 40% of patients treated with tenecteplase and 35% of those treated with alteplase had a modified Rankin score of 0-1 at 90 to 120 days, meeting the prespecified noninferiority threshold (unadjusted risk difference, 2.1%).
In safety analyses, 3.4% of the tenecteplase group and 3.2% of the alteplase group had 24-hour symptomatic intracerebral hemorrhage with no difference in deaths at 90 days after treatment, as reported by Medscape Medical News.
TNKase is also approved for the treatment of acute ST-elevation myocardial infarction in adults.
Complete prescribing information is available online. https://www.gene.com/download/pdf/tnkase_prescribing.pdf
