FDA Approves Genentech's TNKase for Acute Ischemic Stroke in Adults

Genentech, a reputable member of the Roche Group, has gained FDA approval for its thrombolytic medication, TNKase (tenecteplase), marking a pivotal development in the treatment of acute ischemic stroke (AIS) in adults. This marks the first stroke-specific FDA approval in nearly three decades, reinforcing Genentech's commitment to advancing stroke care. Known for developing the only two FDA-approved treatments for AIS, Genentech previously introduced Activase (alteplase) and now adds TNKase to its arsenal.

TNKase stands out due to its simplified administration process. Unlike the existing standard-of-care, Activase—which requires an intricate regimen of an IV bolus followed by a 60-minute infusion—TNKase is administered through a single five-second intravenous bolus. This method provides a swifter and more straightforward alternative, potentially crucial during time-sensitive stroke interventions. To support this recent approval, a new 25 mg vial configuration will soon be available.

Genentech's Chief Medical Officer, Levi Garraway, emphasized the significance of this approval as a leap forward in stroke treatment, underscoring the importance of expedited and uncomplicated medication delivery in managing acute strokes. Stroke remains a critical health issue in the United States, being the fifth leading cause of death and a primary contributor to long-term disability. With over 795,000 stroke incidents annually, timely intervention is essential to prevent irreversible neurological damage.

The FDA's decision was based on a substantial multi-center non-inferiority study that compared TNKase and Activase in terms of safety and efficacy. Conducted by the University of Calgary and supported by the Canadian Institute of Health Research, the AcT trial investigated both medications in patients experiencing acute ischemic stroke with significant neurological deficits. This comprehensive study spanned 22 stroke centers across Canada.

TNKase has already established its efficacy, having been FDA approved for the treatment of acute ST-elevation myocardial infarction (STEMI) in adults. As a tissue plasminogen activator, TNKase acts by initiating a biochemical reaction to break down fibrin, a primary component of blood clots. Despite its effectiveness, common side effects include bleeding and hypersensitivity. The medication label advises administration as promptly as possible, ideally within three hours of the onset of stroke symptoms, to maximize treatment efficacy. This recommendation is also applicable to the treatment of STEMI, where early intervention is critical to reducing mortality risk.

The introduction of TNKase represents Genentech's continued dedication to stroke care, building on decades of neuroscience research and clinical trials. The biotech company, headquartered in South San Francisco, California, has been at the forefront of developing innovative treatments for severe medical conditions for over 40 years. With TNKase and Activase, Genentech solidifies its role as a leader in advancing medical solutions for life-threatening health issues like stroke.