The US Food and Drug Administration (FDA) has approved thrombolysis Tenectase (Tnkase, Genentech) For acute treatment Ischemic stroke adult.
This drug is administered as a single intravenous bolus for 5 seconds. AltePlase (Activase; Genentech), the manufacturer stated in a News Release.
The company has noted that it will introduce a new 25 mg vial configuration in the coming months to support TNKase’s approval in acute ischemic stroke.
Stroke is the fifth leading cause of death, the leading cause of long-term disability in the United States, affecting more than 795,000 people each year.
Tnkase’s approval for acute ischemic stroke was based on the outcome of the conduct (AltePlase compared to Tenectase)) Randomized controlled trialswhich showed that Tene ecteplase is non-aspiraceous in treating patients with acute ischemic stroke within 4.5 hours of onset of symptoms.
Data showed that approximately 40% of patients treated with tenecteplase and 35% of patients treated with alteplase corrected a Rankin score of 0-1 at 90-120 days, meeting a clear non-inferiority threshold (unadjusted risk difference, 2.1%).
Safety analysis showed that 3.4% of the Tenecteplase group and 3.2% of the Alteplase group were symptomatic 24 hours Brain hemorrhage As reported, there is no difference in death 90 days after treatment Medscape Medical News.
Tnkase is approved for treatment of acute ST elevators Myocardial infarction adult.
Complete prescribing information is available online. https://www.gene.com/download/pdf/tnkase_prescribing.pdf
