Genentech, a Roche Group member, has received FDA approval for TNKase (tenecteplase) to treat acute ischemic stroke (AIS) in adults. This marks the company's second AIS treatment approval, reinforcing its leadership in stroke care alongside Activase (alteplase).
TNKase offers a simplified five-second IV bolus administration, compared to Activase, which requires an IV bolus followed by a 60-minute infusion. To support its new approval, Genentech plans to introduce a 25 mg vial configuration in the coming months.
Levi Garraway, M.D., Ph.D., Genentech's Chief Medical Officer, highlighted the approval as a major advancement in stroke treatment, emphasizing TNKase's faster and simpler administration, which is critical in acute stroke cases.
Stroke remains a leading cause of death and long-term disability in the U.S., affecting over 795,000 people annually. Immediate intervention is crucial, as AIS leads to rapid and irreversible brain damage.
The FDA's decision was based on the AcT trial, a large multi-center study demonstrating TNKase's comparable safety and efficacy to Activase. Conducted by the University of Calgary and funded by the Canadian Institute of Health Research, the study involved patients across 22 stroke centers in Canada.
TNKase is also FDA-approved for treating acute ST-elevation myocardial infarction (STEMI) in adults.
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